Interview information.
\r\n\tCell viability is defined as the number of healthy cells in a sample and proliferation of cells is a vital indicator for understanding the mechanisms inaction of certain genes, proteins, and pathways involved in cell survival or death after exposure to toxic agents. The methods used to determine viability are also common for the detection of cell proliferation. A cell viability assay is performed based on the ratio of live and dead cells. This assay is based on an analysis of cell viability in cell culture for evaluating in vitro drug effects in cell-mediated cytotoxicity assays for monitoring cell proliferation. Various methods are involved in performing a cell viability assay, including the dilution method, surface viable count, roll tube technique, nalidixic acid method, fluorogenic dye assay, and the Trypan Blue Cell Viability Assay. The cell viability assays can determine the effect of drug candidates on cells and be used to optimize the cell culture conditions. The parameters that define cell viability can be as diverse as the redox potential of the cell population, the integrity of cell membranes, or the activity of cellular enzymes.
\r\n\tCytotoxicity is the degree to which a substance can cause damage to a cell. Cytotoxicity assays measure the ability of cytotoxic compounds to cause cell damage or cell death. Cytotoxicity assays are widely used in fundamental research and drug discovery to screen libraries for toxic compounds. The cell cytotoxicity and proliferation assays are mainly used for drug screening to detect whether the test molecules have effects on cell proliferation or display direct cytotoxic effects. In a cell-based assay, it is important to know how many viable cells are remaining at the end of the experiment. There are a variety of assay methods based on various cell functions such as enzyme activity, cell membrane permeability, cell adherence, ATP production, co-enzyme production, and nucleotide uptake activity. These methods could be classified in to different categories: (I) dye exclusion methods such as trypan blue dye exclusion assay, (II) methods based on metabolic activity, (III) ATP assay, (IV) sulforhodamine B assay, (V) protease viability marker assay, (VI) clonogenic cell survival assay, (VII) DNA synthesis cell proliferation assays and (V) Raman micro-spectroscopy.
\r\n\tMedical devices have been widely used in various clinical disciplines and these devices have direct contact with the tissues and cells of the body, they should have good physical and chemical properties as well as good biocompatibility. Biocompatibility testing assesses the compatibility of medical devices with a biological system. It studies the interaction between the device and the various types of living tissues and cells exposed to the device when it comes into contact with patients.
\r\n\t
\r\n\tThe book will cover original studies, reviews, all aspects of Cell Viability and Cytotoxicity assays, methods, Biocompatibility of studies of biomedical devices, and related topics.
According to the 2020 biotechnology industry white paper, the global pharmaceutical market in 2019 reached approximately US $1.25 trillion, an increase of 4% compared to 2018. It takes an average of 10–15 years and the US $300–800 million to develop a new drug. Under increasingly strict global supervision, drug development has become more complicated, requiring numerous resources and equipment support. Therefore, reducing development and time costs, and ensuring compliance with strict regulations and standards at the same time, has become a common problem faced by global biotechnology and pharmaceutical companies.
In the entire drug development process, the clinical trial phase requires one-half to two-thirds of the development cost and time. Due to this, clinical trials have been outsourced to the Contract Research Organization (CRO) in recent years. According to Frost & Sullivan estimates, the global CRO turnover in 2019 reached approximately US $49.74 billion, an increase of 8.5% compared to 2018. It can be seen that the clinical trial service industry is very important for biotechnology and medicine. Furthermore, the CRO industry is a knowledge-intensive industry. Professional knowledge and skills are its main requirements, which are also key to the competitiveness of enterprises. Additionally, the accumulation of experience and knowledge, and the maintenance of external relations are both important assets for an enterprise in the clinical trial industry. Therefore, improving the competitiveness of an organization through effective knowledge management has become one of the most important issues in business management.
Previous research on CRO mainly focused on its strategy, business, and operations model, and seldom discussed the knowledge management of CRO. Therefore, this research will focus on the CRO industry and select companies that provide clinical trial services in Taiwan to study their knowledge management practices and the impact of influencing factors on knowledge management activities.
The issues to be discussed in this research are as follows:
What are the main factors affecting the knowledge management of CROs?
What are the main knowledge management activities of CROs?
What is the impact of influencing factors of knowledge management on CROs’ knowledge management activities?
In the following section, an overview of the CRO industry is introduced, as well as related literature on influential factors of knowledge management and knowledge management activities. The research framework is then introduced in the third section based on the research purpose and the literature review results. Besides, in this section, the research method, research objects, and data collection methods of this study are further explained. The fourth section describes the research cases. In the fifth section, seven research propositions are proposed and are followed by discussions. Finally, conclusions are drawn and the theoretical implications are depicted in the last section.
This section discusses the current situation of the clinical trial service industry, the related literature on possible influencing factors of knowledge management, and knowledge management activities.
The Contract Research Organization (CRO) is part of the biotechnology service industry. From the drug development stage to the market launch stage, it works closely with biotechnology and pharmaceutical companies or research institutes to provide services, such as drug discovery, clinical trial planning, assistance in monitoring clinical research, data analysis and management, application review, and post-marketing monitoring, to accelerate product development or launch.
The development of new drugs in global pharmaceutical companies is becoming increasingly complex owing to increasingly stringent regulations. Therefore, along with equipment support, more resources are required, which has increased the demand for entrusted R&D and clinical trial services in the biotechnology and pharmaceutical industries.
According to Frost & Sullivan estimates, the global CRO turnover is expected to grow to US$ 72.54 billion in 2024, with an average annual compound growth rate of 7.8%. North America (the United States and Canada) accounted for the largest proportion of the global CRO market in 2019, accounting for approximately 36.5%, followed by Europe (the United Kingdom, Germany, France, Spain, Italy, Finland, Denmark, Sweden, Norway, Iceland, Netherlands, Belgium, Luxembourg, and other countries in Eastern Europe), accounting for approximately 34.4%. In third place is the Asia-Pacific region (Mainland China, Japan, South Korea, and Southeast Asian countries), accounting for approximately 22.4%. However, in recent years, the number of clinical trial applications in the United States has gradually decreased, while the number of clinical trials in the Asia-Pacific region has increased annually. Combining the benefits of government support for clinical trials and lower trial costs, the future market growth rate of CRO in the Asia-Pacific region is estimated to be the highest among all regions, with an average annual compound growth rate of approximately 10.9%.
The process of drug development is divided into three stages: drug discovery, preclinical trials, and clinical trials. After the pre-clinical trial is completed, the experimental results of R&D, literature, and other data are collected, and the Investigational New Drug (IND) is applied to the drug management agency. After completing the first three phases of clinical trials and confirming the safety and effectiveness of the drug in the human body, New Drug Application Registration (NDA) is applied to the responsible agency to obtain the new drug marketing authorization, although it still needs to continue monitoring medication safety after approval.
To complete the aforementioned drug development process, the average time from laboratory to product launch is 10–15 years, which costs approximately US$ 300–800 million. This is a high price for pharmaceutical companies or biotech medical companies. However, if the development is successful and the patent is obtained, the new drug can achieve high-profit recovery through the umbrella of patents. Therefore, drug development must be done timely, and this reflects the importance of CRO. With help from the CRO’s professional services, effective executions of important and complicated clinical trials can be done in reduced time and cost of development. This also helps pharmaceutical companies or biotech medical companies seize opportunities and make early profits.
Knowledge management (KM) refers to the continuous process of giving the right information to members of the organization in a timely manner to help them take correct actions to improve organizational performance [1, 2]. Besides, refining and developing knowledge-based processes can lead the entire organization to higher innovation performance [3, 4].
Four major motivating factors of knowledge management are identified: (1) Strategy and Leadership: Setting up useful strategies and obtaining the support of the top management will help the implementation of KM, (2) Organizational Culture: Creating an organizational atmosphere where employees are willing to share knowledge with each other, (3) People: The employees in the organization must receive relevant training courses on a regular basis, and a good incentive mechanism should be provided to encourage contributions to KM, and (4) Information Technology: In addition to digitizing the information in the organization, the most important purpose is to speed up employees’ search for required knowledge, to increase the frequency of knowledge reuse [5].
From the perspective of knowledge management procedures, this research firstly integrates and categorizes the literature proposed by scholars in the past, and summarizes the three knowledge management activities that this research intends to explore: (1) knowledge acquisition and absorption, (2) knowledge accumulation and storage, and (3) knowledge diffusion and exchange.
After considering the industrial characteristics of CRO, it is understood that it belongs to a knowledge-intensive industry, and its competitiveness lies in how to help client’s complete clinical trials faster and seize the opportunity to launch. Therefore, this research also adds the activity of “knowledge protection” to examine how the CRO protects its knowledge in the process of knowledge management to avoid the leakage of internal and external knowledge.
Organizations create unique organizational knowledge through absorbing, imitating, digesting, and applying that knowledge, and that knowledge assets in organizations can be obtained by integrating existing or new knowledge through learning, integration, rearrangement, etc. [6, 7, 8]. Additionally, organizations assist internal development by acquiring external knowledge resources [9]. The acquisition methods are divided into five types: (1) complete internal self-development, (2) external assistance for internal development, (3) acquisition from the open market, (4) inter-firm development, and (5) mergers and acquisitions [9]. It is argued, however, that only a small number of companies can fully develop their core capabilities on their own, and most companies still need external knowledge [10]. The same scholar further stated that external sources of technical knowledge include consultants, consumers, national laboratories, suppliers, universities, competitors, and noncompetitive companies [10].
After the organization absorbs knowledge, it needs to accumulate and store knowledge to facilitate its re-diffusion and re-absorption. The purpose is to form an “organizational memory” so that members of the organization can easily obtain and use it at any time. Knowledge accumulation also determines how the organization integrates, applies, and develops the basis of its core capabilities [6].
Knowledge carriers can be classified into two categories: people-oriented and object-oriented. The former means that knowledge can be accumulated in people’s brains through training or mentor-disciple systems. The latter indicates that the knowledge and information can be stored in an information system, a document folder, a product, or a database so that people can access it directly.
It was also proposed that there are four major types of knowledge accumulation carriers: (1) Employee knowledge and skill: Whether the organization has members with high quality, high learning ability and motivation, and diverse knowledge and experience to create and accumulate new knowledge. (2) Physical technical systems: Whether information technology in the organization can effectively support knowledge management. If a member is transferred or leaves the department or job, whether the physical system can retain the member’s assets, such as software programs, databases, hardware equipment, etc. (3) Managerial systems: The accumulation of knowledge among members of the organization is encouraged and supervised through the company’s education, remuneration, and reward systems. These management systems create channels for knowledge acquisition and circulation, and also set up barriers to inappropriate knowledge activities. (4) Values and norms: Values and norms determine what kind of knowledge the organization should create and accumulate, and can also be used as a mechanism for knowledge screening and control [10].
The knowledge accumulated by the organization needs to be diffused and exchanged so that it can be continuously re-absorbed, created, and accumulated, after which, organizational knowledge can continue to develop and grow. Knowledge diffusion is the transferring and sharing of knowledge to the entire organization through various channels, which may occur among individuals, teams, and organizations [11, 12]. Other scholars divided knowledge transfer into five different types, including formal and informal channels: (1) commissioners and face-to-face meetings; (2) pantry and conversation rooms; (3) knowledge exhibition and openness forum; (4) partner cooperation or master-apprentice inheritance, and (5) electronic technology [13, 14].
It was pointed out that five factors that hinder knowledge transfer: (1) a culture of silo mentality, (2) a culture that emphasizes personal expertise and knowledge creation more than knowledge sharing, (3) lack of communication, relationship connections, and common views among members, (4) a culture that relies too much on explicit knowledge but neglects tacit knowledge, and (5) not encouraging or allowing time to learn, share, or assist each other [2].
This research proposes five ways of knowledge transfer in organizations, mainly based on Davenport and Prusak’s research, including formal and informal channels, and discusses the CRO’s knowledge diffusion and exchange actions [13, 14]. This research will further check whether there are factors that hinder the diffusion of knowledge.
Knowledge is a resource that creates competitive advantages. Therefore, to maintain their competitive advantage, companies must make efforts to protect their knowledge. Many companies believe that their knowledge can be protected through patents, trademarks, copyrights, etc. However, not all knowledge can be defined through intellectual property rights. It also needs to be assisted by the employee code of conduct, adjustment of incentives, and job design [15]. Although knowledge protection is inherently difficult, and the existent literature rarely discusses the topic of knowledge protection, it is very important for knowledge-intensive companies.
Scholars proposed that knowledge-intensive service industries usually require employees or knowledge workers to sign confidentiality agreements, competition clauses, or other legally effective formalized contracts to restrict internal company secrets and direct or indirect outflow of customer information to third parties or competitors, while avoiding the possibility of employees changing jobs or malicious talent poaching by competitors [16]. In addition, the knowledge-intensive service industry also incorporates informal mechanisms such as education and training, incentive measures, shaping corporate culture, or establishing relationship connections to enhance employees’ loyalty to the organization, and reduce the risk of professional knowledge leak.
The implementation of knowledge protection may not be as smooth as expected, with possibilities of increased workload for members of the organization, or hindered knowledge sharing or cultural learning, but it is a very important process for the organization. Since the knowledge-intensive service industry relies on expertise in products or services, and knowledge assets are also a source of competitive advantage, organizational knowledge needs to be protected to achieve scarcity and prevent imitation. This research incorporates knowledge protection into knowledge management activities and explores the organization’s activities in knowledge management activity.
In the era of the knowledge economy, knowledge is the most important production resource for organizations and is also the key for organizations to establish their competitive advantage. Knowledge management scholars have always valued issues ranging from acquisition, storage, and sharing for the effective application of knowledge. More companies have gradually realized the importance of knowledge management, which is both a strategy and a process. In this process, there must be factors that promote knowledge management, including organizational structure, organizational culture, personnel factors, and information technology. Therefore, this research analyzes the factors influencing knowledge management and knowledge management activities to understand the relevant actions of enterprises.
In the past, most scholars who conducted research on knowledge management discussed the knowledge management situation of enterprises from the perspective of process, and seldom used and described how knowledge management influences affect knowledge management activities. Therefore, this research analyzes the relationship between the influential factors of knowledge management and knowledge management activities to explore practices of case companies. Based on the literature discussed, this research integrates the elements proposed by previous scholars into four influential factors of knowledge management to explore the activities of case companies, namely “strategy and leadership,” “organizational culture,” “personnel factors,” and “information technology.” For knowledge management activities, this research summarizes the views of knowledge management procedures proposed by previous scholars. After considering the industrial characteristics of CROs, it will be divided into four major activities: “knowledge acquisition and absorption,” “knowledge accumulation and “storage,” “knowledge diffusion and exchange,” and “knowledge protection,” which will be used to study the activities of case companies. In addition, the research focuses on the “execution” phase of clinical trials in the CRO industry. Finally, this research analyzes the relationship between the influential factors of knowledge management and management activities. The research results are expected to contribute to both academia and industry.
The research framework is drawn as shown in Figure 1. This research examines the knowledge management practices of CROs from the perspectives of “influential factors of knowledge management” and “knowledge management activities,” and explores how CROs in Taiwan perform knowledge management activities during the “execution” phase of assisting clinical trials. It then discusses the actual situation regarding the relationship between influential factors of knowledge management and knowledge management activities.
Research framework.
The case study method is regarded as suitable and is proposed for this research to explore the required questions [17]. It focuses on phenomena that occur in real life. Therefore, the experience of researchers is important [17].
Since the research mainly explores the “influential factors of knowledge management” and “knowledge management activities” of CROs in Taiwan, this research adopts the case study method to conduct in-depth interviews for primary information and collect secondary data. After analysis of the real situation of knowledge management in CROs, the research findings, conclusions, and recommendations are derived. This research adopts the multiple cases method with the intention to explore how CROs implement knowledge management and provide suggestions and reference values to other CROs interested in knowledge management.
This research chose two American companies with a branch in Taiwan, a Taiwanese company, and a Japanese company with a branch in Taiwan, as the research objects. The main purpose is to use the heterogeneous background of the CROs to make the analysis and discussion in this research more comprehensive. After comparing the sizes and backgrounds of different CROs, the similarities and differences in their knowledge management practices can be understood. Brief information regarding the four CROs is provided as follows.
IQVIA is a U.S. CRO and one of the top five CROs in the world. The IQVIA has a branch in Taiwan.
PRA Health Science is an American CRO, and it is also one of the top five CROs in the world. It has a branch in Taiwan.
The Formosa Biomedical Technology Corporation (FBTC) is a local Taiwanese biotechnology company. A clinical trial division was formally established in July 1995 to perform CRO-related services. It is one of the most famous CROs in Taiwan and is still actively growing and developing.
A2 Healthcare Corporation (A2HC) in Taiwan is a CRO owned by a Japanese business group. It is currently working hard to deepen its business in Taiwan. Compared to the first three companies, it is a small CRO company.
Table 1 illustrates the interviewees who participated in this research and other related information about the interviews.
Research objects | Interviewees | Job title | Times interviewed | Total hours interviewed |
---|---|---|---|---|
IQVIA | Mr. Lin | CRA | 3 | 6 |
PRA | Ms. Yu | CRA | 3 | 6 |
FBTC | Ms. Chen | PM | 3 | 6 |
A2HC | Ms. Chang | CRA | 2 | 4 |
Interview information.
There are two sources of data collection in this research, with primary data as the main source and secondary data as the supplement. Primary data include in-depth interviews with the internal personnel of the case companies and serve as the basis for deriving results. The interviewees chosen work in roles more relevant to the “execution” phase of the clinical trial: clinical research associate (CRA) and project manager (PM). In addition, the interviews were recorded to increase the accuracy of the records and subsequent data collation. Most of the interview questions were open-ended to avoid restricting the respondents’ answers.
Secondary data was collected to help researchers understand the background, current status, development history, and related operational overview of the case companies. The main sources include official website information, annual reports, public brochures, and public announcements. In addition, industry analysis reports of market research companies and the public sector are also used as reference materials.
IQVIA is a CRO founded in 1982 and headquartered in North Carolina, USA. It was originally named Quintiles. In 2016, it merged with IMS Health to form the Quintiles IMS. In 2017, it was renamed IQVIA. It mainly provides biopharmaceutical development and commercial outsourcing services, including phase I to IV clinical trials, related laboratories, analysis, and consultation. IQVIA is currently one of the top three companies in the global clinical trial service industry. Its global service base exceeds 100 countries, with nearly 70,000 employees. IQVIA provides professional services for many medical fields, including tumor treatment, central nervous system, cardiovascular diseases, autoimmune diseases, urinary system diseases, endocrine diseases, respiratory diseases, and various infectious diseases. So far, IQVIA has helped complete the R&D or commercialization of many best-selling drugs and biologics around the world. It has also helped customers reduce R&D costs and the timetable for R&D, contributing to improving the health of people.
PRA Health Sciences originated from the University of Virginia in Charlotteville, USA in 1976, and established a CRO to assist in data management in 1982. Until 1991, it extended services to clinical trial management, drug safety, etc. Today, it has more than 15,000 employees, more than 75 offices around the world, and provides services in more than 90 countries. As one of the world’s leading CROs, PRA continues to cooperate with biotechnology and pharmaceutical companies, and, like IQVIA, improves the R&D process, conducts drug development, and assists in clinical trials through mergers and acquisitions. At present, PRA provides services for multiple medical fields, including tumors, central nervous system diseases, inflammation, and infectious diseases. Its comprehensive service items include data management, statistical analysis, clinical trial management, supervision, and drug development consulting.
The Formosa Biomedical Technology Corporation (FBTC) was established in 2003. Its purpose is to combine the three major resources of the company in manufacturing, research in universities, and clinical trials. Through cross-field and cross-departmental cooperation, it jointly develops and produces high-quality and high-tech products that are beneficial to human health. In 2006, a clinical trial division was established. With the assistance of medical resources of the Chang Gung Memorial Medical System and the academic resources of Chang Gung University, it received medical materials and commissioned research services from domestic and foreign pharmaceutical companies. It is focusing on contracting at various stages of clinical trial cases and actively looking for partners worldwide. Through clinical experience in progress or completed assistance, it attracts more multinational clinical trials to Taiwan, promotes its business in Europe and the United States, and deploys globally. Currently, Formosa Biomedical Technology Corporation provides the following professional services: (1) clinical research monitoring; (2) test organization management; (3) regulatory services; (4) trial design; (5) data processing; (6) statistical analysis; and (7) trial report writing.
A2 Healthcare Corporation (A2HC) in Taiwan was established in 2012. It performs clinical research services under the Japanese ITOCHU Group and is positioned as a CRO that provides comprehensive clinical research services for customers in Taiwan and overseas. So far, it has executed and accumulated services for 45 clients and more than 60 clinical trial cases worldwide. The service scope ranges from strategic planning, trial planning and execution, data collection and analysis, and research report writing to a closed GCP audit. The detailed items are as follows: (1) clinical research execution; (2) data processing and statistics; (3) medical writing; and (4) overseas clinical trial services.
According to the case study results, several research propositions are raised, illustrated with a case brief, and discussed as follows:
The standard of procedures (SOP) of IQVIA includes some rules of knowledge management practices that employees have to follow. In addition, the company assigns specific staff for designing corresponding training programs and continuously adjusts the rules. PRA not only integrates knowledge management practice requirements into SOP, but also into general clinical practice (GCP), particularly in the areas of knowledge accumulation and protection. They also pay attention to whether employees comply with the regulations. Both FBTC and A2HC integrate the rules of knowledge management accumulation and protection into their training programs and SOPs. In FBTC, the quality assurance (QA) personnel are in charge of the monitoring process, in A2HC, both QA and the heads of divisions are responsible for checking KM implementation.
For the CROs, the accumulation and protection of clinical trial knowledge and results are critical information and are important documents to conduct further analysis and for later authority checks. It is believed that once the rules and processes of knowledge management can be integrated into the SOP, training programs, and daily working life, the concept and importance of knowledge management can be better realized by employees. Thus, a higher performance by CRO firms is expected. Although a few studies have tried to connect knowledge management with operations management, such as [18], very few have addressed how the knowledge management practices are transformed into the SOP.
Both IQVIA and PRA have an obvious knowledge-sharing atmosphere. They organize different groups from different divisions, with group heads in charge of promoting knowledge sharing. These heads monitor the situations of colleagues implementing knowledge management and suggest a change in KM rules to their supervisors when necessary. FBTC and A2HC emphasize knowledge sharing in formal meetings, through which a few cases are discussed. The latter firm also relies heavily on its internal intranet for knowledge sharing, learning, and recording.
A large amount of tacit knowledge exists in the brains of individual employees. This knowledge can be shared with others, and can create values for the organization [9, 19]. Thus, the degree of employees’ willingness to share their knowledge and experiences, usually determined by the organizational culture, is a key factor in knowledge sharing. As for the CROs, many projects are quite similar with only differences in external partners and contractors that may require different working methods. Therefore, if employees working for different groups can share knowledge and techniques with one another, they can improve their knowledge base, capabilities, and work efficiency.
All four case firms have transition SOPs as guidance when employees either shift to new positions, leave offices, or retire. Their transition SOPs include detailed rules, checklists, and procedures. The people in charge of the transition will check if the leaving employee passes on their professional knowledge, experiences, and the required documents. Meanwhile, they need to ensure that the followers can come on track quickly and smoothly.
Research in knowledge management has indicated that individuals drive knowledge processes and are the true source and creator of knowledge [20, 21, 22]. If industrial firms can develop a KM-based human resource management system, then their employees will be in a better position to fuse old and new knowledge. Thus, we can conclude that the top managers of these four firms pay high attention to human resource management, with a particular focus on managing people exchange.
All four case firms rely on the information system to collect and archive the magnanimous data of clinical trials. In addition, the information system serves as an important channel for employees’ communication. They can either share or ask questions to their colleagues through the system. Furthermore, employees can learn from the information system, which stores necessary information for training. Among these cases, IQVIA and FBTC establish a specific information system for dealing with only clinical trial-related data with concerns of data complexity and fear of knowledge leak.
The utilization of information technology or information systems to facilitate knowledge management has been recognized for a long time [23, 24]. The information system possesses the capacity to accumulate large quantities of various types of data useful for new or junior employees to learn, and for project team members to share project-executing experiences. While information systems can be used to facilitate knowledge management, as the knowledge involved is explicit, there still exist limitations when knowledge involved is tacit in nature. Companies need to find other ways, besides information systems, to implement knowledge management.
The project team members of IQVIA organize monthly meetings for experience sharing and learning from one another. The company also builds “buddy” and “mentor” systems, with junior employees as the former and senior employees as the latter, to facilitate knowledge diffusion. PRA employees rely more on informal channels for consultation with experienced colleagues for knowledge learning. Through the knowledge exchange process, new knowledge can be created. Both FBTC and A2HC emphasize “on-job-training” for training new employees and those in new positions to be equipped with the necessary knowledge and skills for new jobs as soon as possible. A2HC also holds workshops for new employee training and quick learning.
From the case study results, we can conclude that CROs use mentoring systems to assist new and junior employees to learn from senior and experienced employees. The major experiences of CROs’ employees may include communication skills with hospitals (mainly medical doctors and nurses) and contractors (biotechnological and pharmaceutical companies), accumulated knowledge about clinical trials, and analytical skills from the clinical trial data check. The characteristics of this type of tacit knowledge are regarded as different from those based on information systems and databases [20].
All four case firms take three major knowledge protection actions: signing confidentiality agreements with clients and employees, establishing the codes of conduct in the SOP for knowledge protection, and setting the information access limit to authority. The first action belongs to formal and legal mechanisms, while the second and third actions belong to informal mechanisms.
Knowledge of intellectual property, particularly in the manufacturing sector, is usually protected in legal terms, such as patents, copyrights, trademarks, and trade secrets. However, it is argued that the protection mechanisms in the service sector need to be broadened to include other mechanisms [25]. Scholars claimed that knowledge-intensive business services (KIBS) firms can include other mechanisms for protection, such as complexity of design, lead-time advantages on competitors, education and training, codes of conduct, and incentive measures in addition to legal methods [16, 26]. As the CROs’ data and results of clinical trials are very important to their pharmaceutical clients, they must strive to protect them.
All four case firms are found to support KM activities of knowledge management. However, different firms may have different incentive systems. For example, PRA has an incentive mechanism called “star system.” Once employees have particular achievements in KM-related activities, they would be credited with a certain number of stars, which later becomes one of the major criteria for salary raises and promotion. A2HC designed an evaluation form with a checklist to check how knowledge sharing and exchange is implemented when people change with new positions.
It is indicated that more support for knowledge sharing by top management makes it easier for employees to implement knowledge-sharing activities [27]. Other studies have also indicated the crucial role of leadership in knowledge sharing [28]. With enough support from top management, employees would be encouraged to put efforts into keeping important data safe, storing, and sharing knowledge. Consequently, firms will have a higher performance in knowledge exchange and accumulation.
The study draws several conclusions. When an organization implements knowledge management, if it can integrate the concepts and objectives of knowledge management into the staff’s standard procedures of daily work by matching education and training courses, it can become deeply rooted in the staff’s daily work. Even if knowledge management is not clear by definition, employees can still improve their participation in knowledge management activities through daily work processes. Therefore, companies would construct a set of suitable norms for employees to follow so that knowledge management becomes a part of daily work norms and knowledge accumulation and knowledge protection activities can be carried out more reliably.
Furthermore, due to the nature of CRO employees’ work, they rely heavily on the absorption of empirical knowledge, including communication skills with the hospitals and the clients, familiarity with the clinical trial process, clinical trial data recording, and review skills, etc. Such knowledge acquisition is necessary for experience sharing in the organization to allow employees to communicate with each other through the mentoring system, or experience and knowledge sharing activities similar to the mentoring system, to achieve the purpose of imparting and spreading experience and knowledge. In addition, the establishment of information technology can provide a systematic platform for employees of the company to record, integrate, and transfer knowledge to improve the efficiency of knowledge diffusion and exchange.
Additionally, when CROs implement knowledge management, they emphasize the support of the leadership and the coordination of the improved human resource management system for knowledge diffusion and accumulation. The higher the support of the organization’s leadership for knowledge management, the higher the willingness of employees to participate in knowledge management activities. A robust human resource management system, including the design of rewards or performance evaluation systems, can increase employees’ motivation for knowledge diffusion and communication. Clear handover specifications can avoid loss of experience and knowledge during the movement of personnel. Thus, it can promote the easier implementation of accumulation and storage of knowledge.
Whether it comes from the internal norms of the organization, the content of clinical trial books, the acquisition of relevant prior knowledge, or the absorption of updated knowledge from outside the organization on regulatory and implementation aspects, knowledge management can improve the efficiency of the organization members in the implementation of the clinical trial. With this knowledge, when faced with the needs and questions of the clients and the hospital staff, they can quickly answer and carry out diffusion and exchange of knowledge.
According to the above conclusions, this research provides two major academic contributions. First of all, the study takes CROs as the objects to explore the “integrity” of knowledge management. The CRO industry is a knowledge-intensive industry. Although several prior researches have been conducted on its strategic aspects, business, and operating models, the knowledge management of CROs have seldom been discussed. Therefore, this research focuses on the CRO industry and selects institutions that provide clinical trial services to explore their knowledge management practices and the impact of influential factors on knowledge management activities.
In past empirical research on knowledge management, there have been more discussions on the influential factors of knowledge management or knowledge management activities in a single dimension. The results of these studies may have several limitations. Based on the perspective of “integrity,” this research explores four aspects of knowledge management: strategy and leadership, organizational culture, human factors, and information technology; and four aspects of knowledge management activities: knowledge creation and absorption, knowledge accumulation and storage, knowledge diffusion and exchange, and knowledge protection. This is expected to contribute to a holistic approach to knowledge management studies.
Second, this research takes the organizational level as the unit of analysis to conduct empirical research on knowledge management. Past empirical studies on knowledge management mostly focused on the “project level” or “individual tintegrated research, especially with the “organization level” as the unit of analysis. Knowledge management of CROs is expected to be helpful in the research field of knowledge management at the organizational level.
Authors are listed below with their open access chapters linked via author name:
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\\n\\n\\n\\n\\n\\n\\n\\n\\n\\nJocelyn Chanussot (chapter to be published soon...)
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\\n\\nKhalil Amine 2017, 2018
\\n\\nEwan Birney 2015-18
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\\n\\nLiming Dai 2015-18
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\\n\\nVincenzo Fogliano 2017, 2018
\\n\\nRon de Graaf 2014-18
\\n\\nHarald Haas 2017, 2018
\\n\\nFrancisco Herrera 2017, 2018
\\n\\nJaakko Kangasjärvi 2015-18
\\n\\nHamid Reza Karimi 2016-18
\\n\\nJunji Kido 2014-18
\\n\\nJose Luiszamorano 2015-18
\\n\\nYiqi Luo 2016-18
\\n\\nJoachim Maier 2014-18
\\n\\nAndrea Natale 2017, 2018
\\n\\nAlberto Mantovani 2014-18
\\n\\nMarjan Mernik 2017, 2018
\\n\\nSandra Orchard 2014, 2016-18
\\n\\nMohamed Oukka 2016-18
\\n\\nBiswajeet Pradhan 2016-18
\\n\\nDirk Raes 2017, 2018
\\n\\nUlrike Ravens-Sieberer 2016-18
\\n\\nYexiang Tong 2017, 2018
\\n\\nJim Van Os 2015-18
\\n\\nLong Wang 2017, 2018
\\n\\nFei Wei 2016-18
\\n\\nIoannis Xenarios 2017, 2018
\\n\\nQi Xie 2016-18
\\n\\nXin-She Yang 2017, 2018
\\n\\nYulong Yin 2015, 2017, 2018
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\n\nJoachim Maier 2014-18
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\n\nAlberto Mantovani 2014-18
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\n\nFei Wei 2016-18
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The evolutions of Machine Learning (ML) and the Internet of Things (IoT) have supported researchers to implement this automation in agriculture to support farmers. ML allows farmers to improve yield make use of effective land utilisation, the fruitfulness of the soil, level of water, mineral insufficiencies control pest, trim development and horticulture. Application of remote sensors like temperature, humidity, soil moisture, water level sensors and pH value will provide an idea to on active farming, which will show accuracy as well as practical agriculture to deal with challenges in the field. This advancement could empower agricultural management systems to handle farm data in an orchestrated manner and increase the agribusiness by formulating effective strategies. 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Radiotherapy and Nuclear Medicine Technology has always been my aspiration and my life. As years passed I accumulated a tremendous amount of skills and knowledge in Radiotherapy and Nuclear Medicine, Conventional Radiology, Radiation Protection, Bioinformatics Technology, PACS, Image processing, clinically and lecturing that will enable me to provide a valuable service to the community as a Researcher and Consultant in this field. 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He is the author or co-author of more than seventy papers in peer-reviewed journals and conferences as well as the co-author of several books. He serves as a reviewer for many scientific journals, international conferences, and research foundations. Since 2010, Dr. Placzek has been a reviewer of grants and projects (including EU projects) in the field of information technologies.",institutionString:"University of Silesia",institution:{name:"University of Silesia",country:{name:"Poland"}}},{id:"35000",title:"Prof.",name:"Ulrich H.P",middleName:"H.P.",surname:"Fischer",slug:"ulrich-h.p-fischer",fullName:"Ulrich H.P Fischer",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/35000/images/3052_n.jpg",biography:"Academic and Professional Background\nUlrich H. P. has Diploma and PhD degrees in Physics from the Free University Berlin, Germany. He has been working on research positions in the Heinrich-Hertz-Institute in Germany. Several international research projects has been performed with European partners from France, Netherlands, Norway and the UK. He is currently Professor of Communications Systems at the Harz University of Applied Sciences, Germany.\n\nPublications and Publishing\nHe has edited one book, a special interest book about ‘Optoelectronic Packaging’ (VDE, Berlin, Germany), and has published over 100 papers and is owner of several international patents for WDM over POF key elements.\n\nKey Research and Consulting Interests\nUlrich’s research activity has always been related to Spectroscopy and Optical Communications Technology. Specific current interests include the validation of complex instruments, and the application of VR technology to the development and testing of measurement systems. He has been reviewer for several publications of the Optical Society of America\\'s including Photonics Technology Letters and Applied Optics.\n\nPersonal Interests\nThese include motor cycling in a very relaxed manner and performing martial arts.",institutionString:null,institution:{name:"Charité",country:{name:"Germany"}}},{id:"341622",title:"Ph.D.",name:"Eduardo",middleName:null,surname:"Rojas Alvarez",slug:"eduardo-rojas-alvarez",fullName:"Eduardo Rojas Alvarez",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/341622/images/15892_n.jpg",biography:null,institutionString:null,institution:{name:"University of Cuenca",country:{name:"Ecuador"}}},{id:"215610",title:"Prof.",name:"Muhammad",middleName:null,surname:"Sarfraz",slug:"muhammad-sarfraz",fullName:"Muhammad Sarfraz",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/215610/images/system/215610.jpeg",biography:"Muhammad Sarfraz is a professor in the Department of Information Science, Kuwait University, Kuwait. His research interests include optimization, computer graphics, computer vision, image processing, machine learning, pattern recognition, soft computing, data science, and intelligent systems. Prof. Sarfraz has been a keynote/invited speaker at various platforms around the globe. He has advised/supervised more than 110 students for their MSc and Ph.D. theses. He has published more than 400 publications as books, journal articles, and conference papers. He has authored and/or edited around seventy books. Prof. Sarfraz is a member of various professional societies. He is a chair and member of international advisory committees and organizing committees of numerous international conferences. He is also an editor and editor in chief for various international journals.",institutionString:"Kuwait University",institution:{name:"Kuwait University",country:{name:"Kuwait"}}},{id:"32650",title:"Prof.",name:"Lukas",middleName:"Willem",surname:"Snyman",slug:"lukas-snyman",fullName:"Lukas Snyman",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/32650/images/4136_n.jpg",biography:"Lukas Willem Snyman received his basic education at primary and high schools in South Africa, Eastern Cape. He enrolled at today's Nelson Metropolitan University and graduated from this university with a BSc in Physics and Mathematics, B.Sc Honors in Physics, MSc in Semiconductor Physics, and a Ph.D. in Semiconductor Physics in 1987. After his studies, he chose an academic career and devoted his energy to the teaching of physics to first, second, and third-year students. 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In subsequent years, the concept of 'telematic education” subsequently becomes well established in academic circles in South Africa, grew in popularity, and is adopted by many universities and colleges throughout South Africa as a medium of enhancing education and training, as a method to reaching out to far out communities, and as a means to enhance study from the home environment.\r\n\r\nProfessor Snyman in subsequent years pursued research in semiconductor physics, semiconductor devices, microelectronics, and optoelectronics.\r\n\r\nIn 2000 he joined the TUT as a full professor. Here served for a period as head of the Department of Electronic Engineering. Here he makes contributions to solar energy development, microwave and optoelectronic device development, silicon photonics, as well as contributions to new mobile telecommunication systems and network planning in SA.\r\n\r\nCurrently, he teaches electronics and telecommunications at the TUT to audiences ranging from first-year students to Ph.D. level.\r\n\r\nFor his research in the field of 'Silicon Photonics” since 1990, he has published (as author and co-author) about thirty internationally reviewed articles in scientific journals, contributed to more than forty international conferences, about 25 South African provisional patents (as inventor and co-inventor), 8 PCT international patent applications until now. Of these, two USA patents applications, two European Patents, two Korean patents, and ten SA patents have been granted. A further 4 USA patents, 5 European patents, 3 Korean patents, 3 Chinese patents, and 3 Japanese patents are currently under consideration.\r\n\r\nRecently he has also published an extensive scholarly chapter in an internet open access book on 'Integrating Microphotonic Systems and MOEMS into standard Silicon CMOS Integrated circuitry”.\r\n\r\nFurthermore, Professor Snyman recently steered a new initiative at the TUT by introducing a 'Laboratory for Innovative Electronic Systems ' at the Department of Electrical Engineering. The model of this laboratory or center is to primarily combine outputs as achieved by high-level research with lower-level system development and entrepreneurship in a technical university environment. Students are allocated to projects at different levels with PhDs and Master students allocated to the generation of new knowledge and new technologies, while students at the diploma and Baccalaureus level are allocated to electronic systems development with a direct and a near application for application in industry or the commercial and public sectors in South Africa.\r\n\r\nProfessor Snyman received the WIRSAM Award of 1983 and the WIRSAM Award in 1985 in South Africa for best research papers by a young scientist at two international conferences on electron microscopy in South Africa. He subsequently received the SA Microelectronics Award for the best dissertation emanating from studies executed at a South African university in the field of Physics and Microelectronics in South Africa in 1987. In October of 2011, Professor Snyman received the prestigious Institutional Award for 'Innovator of the Year” for 2010 at the Tshwane University of Technology, South Africa. This award was based on the number of patents recognized and granted by local and international institutions as well as for his contributions concerning innovation at the TUT.",institutionString:null,institution:{name:"University of South Africa",country:{name:"South Africa"}}},{id:"317279",title:"Mr.",name:"Ali",middleName:"Usama",surname:"Syed",slug:"ali-syed",fullName:"Ali Syed",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/317279/images/16024_n.png",biography:"A creative, talented, and innovative young professional who is dedicated, well organized, and capable research fellow with two years of experience in graduate-level research, published in engineering journals and book, with related expertise in Bio-robotics, equally passionate about the aesthetics of the mechanical and electronic system, obtained expertise in the use of MS Office, MATLAB, SolidWorks, LabVIEW, Proteus, Fusion 360, having a grasp on python, C++ and assembly language, possess proven ability in acquiring research grants, previous appointments with social and educational societies with experience in administration, current affiliations with IEEE and Web of Science, a confident presenter at conferences and teacher in classrooms, able to explain complex information to audiences of all levels.",institutionString:null,institution:{name:"Air University",country:{name:"Pakistan"}}},{id:"75526",title:"Ph.D.",name:"Zihni Onur",middleName:null,surname:"Uygun",slug:"zihni-onur-uygun",fullName:"Zihni Onur Uygun",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/75526/images/12_n.jpg",biography:"My undergraduate education and my Master of Science educations at Ege University and at Çanakkale Onsekiz Mart University have given me a firm foundation in Biochemistry, Analytical Chemistry, Biosensors, Bioelectronics, Physical Chemistry and Medicine. After obtaining my degree as a MSc in analytical chemistry, I started working as a research assistant in Ege University Medical Faculty in 2014. In parallel, I enrolled to the MSc program at the Department of Medical Biochemistry at Ege University to gain deeper knowledge on medical and biochemical sciences as well as clinical chemistry in 2014. In my PhD I deeply researched on biosensors and bioelectronics and finished in 2020. Now I have eleven SCI-Expanded Index published papers, 6 international book chapters, referee assignments for different SCIE journals, one international patent pending, several international awards, projects and bursaries. In parallel to my research assistant position at Ege University Medical Faculty, Department of Medical Biochemistry, in April 2016, I also founded a Start-Up Company (Denosens Biotechnology LTD) by the support of The Scientific and Technological Research Council of Turkey. Currently, I am also working as a CEO in Denosens Biotechnology. The main purposes of the company, which carries out R&D as a research center, are to develop new generation biosensors and sensors for both point-of-care diagnostics; such as glucose, lactate, cholesterol and cancer biomarker detections. My specific experimental and instrumental skills are Biochemistry, Biosensor, Analytical Chemistry, Electrochemistry, Mobile phone based point-of-care diagnostic device, POCTs and Patient interface designs, HPLC, Tandem Mass Spectrometry, Spectrophotometry, ELISA.",institutionString:null,institution:{name:"Ege University",country:{name:"Turkey"}}},{id:"246502",title:"Dr.",name:"Jaya T.",middleName:"T",surname:"Varkey",slug:"jaya-t.-varkey",fullName:"Jaya T. Varkey",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/246502/images/11160_n.jpg",biography:"Jaya T. Varkey, PhD, graduated with a degree in Chemistry from Cochin University of Science and Technology, Kerala, India. She obtained a PhD in Chemistry from the School of Chemical Sciences, Mahatma Gandhi University, Kerala, India, and completed a post-doctoral fellowship at the University of Minnesota, USA. She is a research guide at Mahatma Gandhi University and Associate Professor in Chemistry, St. Teresa’s College, Kochi, Kerala, India.\nDr. Varkey received a National Young Scientist award from the Indian Science Congress (1995), a UGC Research award (2016–2018), an Indian National Science Academy (INSA) Visiting Scientist award (2018–2019), and a Best Innovative Faculty award from the All India Association for Christian Higher Education (AIACHE) (2019). She Hashas received the Sr. Mary Cecil prize for best research paper three times. She was also awarded a start-up to develop a tea bag water filter. \nDr. Varkey has published two international books and twenty-seven international journal publications. She is an editorial board member for five international journals.",institutionString:"St. Teresa’s College",institution:null},{id:"250668",title:"Dr.",name:"Ali",middleName:null,surname:"Nabipour Chakoli",slug:"ali-nabipour-chakoli",fullName:"Ali Nabipour Chakoli",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/250668/images/system/250668.jpg",biography:"Academic Qualification:\r\n•\tPhD in Materials Physics and Chemistry, From: Sep. 2006, to: Sep. 2010, School of Materials Science and Engineering, Harbin Institute of Technology, Thesis: Structure and Shape Memory Effect of Functionalized MWCNTs/poly (L-lactide-co-ε-caprolactone) Nanocomposites. Supervisor: Prof. Wei Cai,\r\n•\tM.Sc in Applied Physics, From: 1996, to: 1998, Faculty of Physics & Nuclear Science, Amirkabir Uni. of Technology, Tehran, Iran, Thesis: Determination of Boron in Micro alloy Steels with solid state nuclear track detectors by neutron induced auto radiography, Supervisors: Dr. M. Hosseini Ashrafi and Dr. A. Hosseini.\r\n•\tB.Sc. in Applied Physics, From: 1991, to: 1996, Faculty of Physics & Nuclear Science, Amirkabir Uni. of Technology, Tehran, Iran, Thesis: Design of shielding for Am-Be neutron sources for In Vivo neutron activation analysis, Supervisor: Dr. M. Hosseini Ashrafi.\r\n\r\nResearch Experiences:\r\n1.\tNanomaterials, Carbon Nanotubes, Graphene: Synthesis, Functionalization and Characterization,\r\n2.\tMWCNTs/Polymer Composites: Fabrication and Characterization, \r\n3.\tShape Memory Polymers, Biodegradable Polymers, ORC, Collagen,\r\n4.\tMaterials Analysis and Characterizations: TEM, SEM, XPS, FT-IR, Raman, DSC, DMA, TGA, XRD, GPC, Fluoroscopy, \r\n5.\tInteraction of Radiation with Mater, Nuclear Safety and Security, NDT(RT),\r\n6.\tRadiation Detectors, Calibration (SSDL),\r\n7.\tCompleted IAEA e-learning Courses:\r\nNuclear Security (15 Modules),\r\nNuclear Safety:\r\nTSA 2: Regulatory Protection in Occupational Exposure,\r\nTips & Tricks: Radiation Protection in Radiography,\r\nSafety and Quality in Radiotherapy,\r\nCourse on Sealed Radioactive Sources,\r\nCourse on Fundamentals of Environmental Remediation,\r\nCourse on Planning for Environmental Remediation,\r\nKnowledge Management Orientation Course,\r\nFood Irradiation - Technology, Applications and Good Practices,\r\nEmployment:\r\nFrom 2010 to now: Academic staff, Nuclear Science and Technology Research Institute, Kargar Shomali, Tehran, Iran, P.O. Box: 14395-836.\r\nFrom 1997 to 2006: Expert of Materials Analysis and Characterization. Research Center of Agriculture and Medicine. Rajaeeshahr, Karaj, Iran, P. O. Box: 31585-498.",institutionString:"Atomic Energy Organization of Iran",institution:{name:"Atomic Energy Organization of Iran",country:{name:"Iran"}}},{id:"248279",title:"Dr.",name:"Monika",middleName:"Elzbieta",surname:"Machoy",slug:"monika-machoy",fullName:"Monika Machoy",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/248279/images/system/248279.jpeg",biography:"Monika Elżbieta Machoy, MD, graduated with distinction from the Faculty of Medicine and Dentistry at the Pomeranian Medical University in 2009, defended her PhD thesis with summa cum laude in 2016 and is currently employed as a researcher at the Department of Orthodontics of the Pomeranian Medical University. She expanded her professional knowledge during a one-year scholarship program at the Ernst Moritz Arndt University in Greifswald, Germany and during a three-year internship at the Technical University in Dresden, Germany. She has been a speaker at numerous orthodontic conferences, among others, American Association of Orthodontics, European Orthodontic Symposium and numerous conferences of the Polish Orthodontic Society. She conducts research focusing on the effect of orthodontic treatment on dental and periodontal tissues and the causes of pain in orthodontic patients.",institutionString:"Pomeranian Medical University",institution:{name:"Pomeranian Medical University",country:{name:"Poland"}}},{id:"252743",title:"Prof.",name:"Aswini",middleName:"Kumar",surname:"Kar",slug:"aswini-kar",fullName:"Aswini Kar",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/252743/images/10381_n.jpg",biography:"uploaded in cv",institutionString:null,institution:{name:"KIIT University",country:{name:"India"}}},{id:"204256",title:"Dr.",name:"Anil",middleName:"Kumar",surname:"Kumar Sahu",slug:"anil-kumar-sahu",fullName:"Anil Kumar Sahu",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/204256/images/14201_n.jpg",biography:"I have nearly 11 years of research and teaching experience. I have done my master degree from University Institute of Pharmacy, Pt. Ravi Shankar Shukla University, Raipur, Chhattisgarh India. I have published 16 review and research articles in international and national journals and published 4 chapters in IntechOpen, the world’s leading publisher of Open access books. I have presented many papers at national and international conferences. I have received research award from Indian Drug Manufacturers Association in year 2015. My research interest extends from novel lymphatic drug delivery systems, oral delivery system for herbal bioactive to formulation optimization.",institutionString:null,institution:{name:"Chhattisgarh Swami Vivekanand Technical University",country:{name:"India"}}},{id:"253468",title:"Dr.",name:"Mariusz",middleName:null,surname:"Marzec",slug:"mariusz-marzec",fullName:"Mariusz Marzec",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/253468/images/system/253468.png",biography:"An assistant professor at Department of Biomedical Computer Systems, at Institute of Computer Science, Silesian University in Katowice. Scientific interests: computer analysis and processing of images, biomedical images, databases and programming languages. He is an author and co-author of scientific publications covering analysis and processing of biomedical images and development of database systems.",institutionString:"University of Silesia",institution:null},{id:"212432",title:"Prof.",name:"Hadi",middleName:null,surname:"Mohammadi",slug:"hadi-mohammadi",fullName:"Hadi Mohammadi",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/212432/images/system/212432.jpeg",biography:"Dr. Hadi Mohammadi is a biomedical engineer with hands-on experience in the design and development of many engineering structures and medical devices through various projects that he has been involved in over the past twenty years. Dr. Mohammadi received his BSc. and MSc. degrees in Mechanical Engineering from Sharif University of Technology, Tehran, Iran, and his PhD. degree in Biomedical Engineering (biomaterials) from the University of Western Ontario. He was a postdoctoral trainee for almost four years at University of Calgary and Harvard Medical School. He is an industry innovator having created the technology to produce lifelike synthetic platforms that can be used for the simulation of almost all cardiovascular reconstructive surgeries. He’s been heavily involved in the design and development of cardiovascular devices and technology for the past 10 years. He is currently an Assistant Professor with the University of British Colombia, Canada.",institutionString:"University of British Columbia",institution:{name:"University of British Columbia",country:{name:"Canada"}}},{id:"254463",title:"Prof.",name:"Haisheng",middleName:null,surname:"Yang",slug:"haisheng-yang",fullName:"Haisheng Yang",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/254463/images/system/254463.jpeg",biography:"Haisheng Yang, Ph.D., Professor and Director of the Department of Biomedical Engineering, College of Life Science and Bioengineering, Beijing University of Technology. He received his Ph.D. degree in Mechanics/Biomechanics from Harbin Institute of Technology (jointly with University of California, Berkeley). Afterwards, he worked as a Postdoctoral Research Associate in the Purdue Musculoskeletal Biology and Mechanics Lab at the Department of Basic Medical Sciences, Purdue University, USA. He also conducted research in the Research Centre of Shriners Hospitals for Children-Canada at McGill University, Canada. Dr. Yang has over 10 years research experience in orthopaedic biomechanics and mechanobiology of bone adaptation and regeneration. He earned an award from Beijing Overseas Talents Aggregation program in 2017 and serves as Beijing Distinguished Professor.",institutionString:"Beijing University of Technology",institution:null},{id:"255757",title:"Dr.",name:"Igor",middleName:"Victorovich",surname:"Lakhno",slug:"igor-lakhno",fullName:"Igor Lakhno",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/255757/images/system/255757.jpg",biography:"Lakhno Igor Victorovich was born in 1971 in Kharkiv (Ukraine). \nMD – 1994, Kharkiv National Medical Univesity.\nOb&Gyn; – 1997, master courses in Kharkiv Medical Academy of Postgraduate Education.\nPhD – 1999, Kharkiv National Medical Univesity.\nDSc – 2019, PL Shupik National Academy of Postgraduate Education \nLakhno Igor has been graduated from an international training courses on reproductive medicine and family planning held in Debrecen University (Hungary) in 1997. Since 1998 Lakhno Igor has worked as an associate professor of the department of obstetrics and gynecology of VN Karazin National University and an associate professor of the perinatology, obstetrics and gynecology department of Kharkiv Medical Academy of Postgraduate Education. Since June 2019 he’s a professor of the department of obstetrics and gynecology of VN Karazin National University and a professor of the perinatology, obstetrics and gynecology department of Kharkiv Medical Academy of Postgraduate Education . He’s an author of about 200 printed works and there are 17 of them in Scopus or Web of Science databases. Lakhno Igor is a rewiever of Journal of Obstetrics and Gynaecology (Taylor and Francis), Informatics in Medicine Unlocked (Elsevier), The Journal of Obstetrics and Gynecology Research (Wiley), Endocrine, Metabolic & Immune Disorders-Drug Targets (Bentham Open), The Open Biomedical Engineering Journal (Bentham Open), etc. He’s defended a dissertation for DSc degree \\'Pre-eclampsia: prediction, prevention and treatment”. Lakhno Igor has participated as a speaker in several international conferences and congresses (International Conference on Biological Oscillations April 10th-14th 2016, Lancaster, UK, The 9th conference of the European Study Group on Cardiovascular Oscillations). His main scientific interests: obstetrics, women’s health, fetal medicine, cardiovascular medicine.",institutionString:"V.N. Karazin Kharkiv National University",institution:{name:"Kharkiv Medical Academy of Postgraduate Education",country:{name:"Ukraine"}}},{id:"89721",title:"Dr.",name:"Mehmet",middleName:"Cuneyt",surname:"Ozmen",slug:"mehmet-ozmen",fullName:"Mehmet Ozmen",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/89721/images/7289_n.jpg",biography:null,institutionString:null,institution:{name:"Gazi University",country:{name:"Turkey"}}},{id:"243698",title:"M.D.",name:"Xiaogang",middleName:null,surname:"Wang",slug:"xiaogang-wang",fullName:"Xiaogang Wang",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/243698/images/system/243698.png",biography:"Dr. Xiaogang Wang, a faculty member of Shanxi Eye Hospital specializing in the treatment of cataract and retinal disease and a tutor for postgraduate students of Shanxi Medical University, worked in the COOL Lab as an international visiting scholar under the supervision of Dr. David Huang and Yali Jia from October 2012 through November 2013. Dr. Wang earned an MD from Shanxi Medical University and a Ph.D. from Shanghai Jiao Tong University. Dr. Wang was awarded two research project grants focused on multimodal optical coherence tomography imaging and deep learning in cataract and retinal disease, from the National Natural Science Foundation of China. He has published around 30 peer-reviewed journal papers and four book chapters and co-edited one book.",institutionString:"Shanxi Eye Hospital",institution:{name:"Shanxi Eye Hospital",country:{name:"China"}}},{id:"242893",title:"Ph.D. Student",name:"Joaquim",middleName:null,surname:"De Moura",slug:"joaquim-de-moura",fullName:"Joaquim De Moura",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/242893/images/7133_n.jpg",biography:"Joaquim de Moura received his degree in Computer Engineering in 2014 from the University of A Coruña (Spain). In 2016, he received his M.Sc degree in Computer Engineering from the same university. He is currently pursuing his Ph.D degree in Computer Science in a collaborative project between ophthalmology centers in Galicia and the University of A Coruña. His research interests include computer vision, machine learning algorithms and analysis and medical imaging processing of various kinds.",institutionString:null,institution:{name:"University of A Coruña",country:{name:"Spain"}}},{id:"267434",title:"Dr.",name:"Rohit",middleName:null,surname:"Raja",slug:"rohit-raja",fullName:"Rohit Raja",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002bRZkkQAG/Profile_Picture_2022-05-09T12:55:18.jpg",biography:null,institutionString:null,institution:null},{id:"294334",title:"B.Sc.",name:"Marc",middleName:null,surname:"Bruggeman",slug:"marc-bruggeman",fullName:"Marc Bruggeman",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/294334/images/8242_n.jpg",biography:"Chemical engineer graduate, with a passion for material science and specific interest in polymers - their near infinite applications intrigue me. \n\nI plan to continue my scientific career in the field of polymeric biomaterials as I am fascinated by intelligent, bioactive and biomimetic materials for use in both consumer and medical applications.",institutionString:null,institution:null},{id:"244950",title:"Dr.",name:"Salvatore",middleName:null,surname:"Di Lauro",slug:"salvatore-di-lauro",fullName:"Salvatore Di Lauro",position:null,profilePictureURL:"https://intech-files.s3.amazonaws.com/0030O00002bSF1HQAW/ProfilePicture%202021-12-20%2014%3A54%3A14.482",biography:"Name:\n\tSALVATORE DI LAURO\nAddress:\n\tHospital Clínico Universitario Valladolid\nAvda Ramón y Cajal 3\n47005, Valladolid\nSpain\nPhone number: \nFax\nE-mail:\n\t+34 983420000 ext 292\n+34 983420084\nsadilauro@live.it\nDate and place of Birth:\nID Number\nMedical Licence \nLanguages\t09-05-1985. Villaricca (Italy)\n\nY1281863H\n474707061\nItalian (native language)\nSpanish (read, written, spoken)\nEnglish (read, written, spoken)\nPortuguese (read, spoken)\nFrench (read)\n\t\t\nCurrent position (title and company)\tDate (Year)\nVitreo-Retinal consultant in ophthalmology. Hospital Clinico Universitario Valladolid. Sacyl. National Health System.\nVitreo-Retinal consultant in ophthalmology. Instituto Oftalmologico Recoletas. Red Hospitalaria Recoletas. Private practise.\t2017-today\n\n2019-today\n\t\n\t\nEducation (High school, university and postgraduate training > 3 months)\tDate (Year)\nDegree in Medicine and Surgery. University of Neaples 'Federico II”\nResident in Opthalmology. Hospital Clinico Universitario Valladolid\nMaster in Vitreo-Retina. IOBA. University of Valladolid\nFellow of the European Board of Ophthalmology. Paris\nMaster in Research in Ophthalmology. University of Valladolid\t2003-2009\n2012-2016\n2016-2017\n2016\n2012-2013\n\t\nEmployments (company and positions)\tDate (Year)\nResident in Ophthalmology. Hospital Clinico Universitario Valladolid. Sacyl.\nFellow in Vitreo-Retina. IOBA. University of Valladolid\nVitreo-Retinal consultant in ophthalmology. Hospital Clinico Universitario Valladolid. Sacyl. National Health System.\nVitreo-Retinal consultant in ophthalmology. Instituto Oftalmologico Recoletas. Red Hospitalaria Recoletas. \n\t2012-2016\n2016-2017\n2017-today\n\n2019-Today\n\n\n\t\nClinical Research Experience (tasks and role)\tDate (Year)\nAssociated investigator\n\n' FIS PI20/00740: DESARROLLO DE UNA CALCULADORA DE RIESGO DE\nAPARICION DE RETINOPATIA DIABETICA BASADA EN TECNICAS DE IMAGEN MULTIMODAL EN PACIENTES DIABETICOS TIPO 1. Grant by: Ministerio de Ciencia e Innovacion \n\n' (BIO/VA23/14) Estudio clínico multicéntrico y prospectivo para validar dos\nbiomarcadores ubicados en los genes p53 y MDM2 en la predicción de los resultados funcionales de la cirugía del desprendimiento de retina regmatógeno. Grant by: Gerencia Regional de Salud de la Junta de Castilla y León.\n' Estudio multicéntrico, aleatorizado, con enmascaramiento doble, en 2 grupos\nparalelos y de 52 semanas de duración para comparar la eficacia, seguridad e inmunogenicidad de SOK583A1 respecto a Eylea® en pacientes con degeneración macular neovascular asociada a la edad' (CSOK583A12301; N.EUDRA: 2019-004838-41; FASE III). Grant by Hexal AG\n\n' Estudio de fase III, aleatorizado, doble ciego, con grupos paralelos, multicéntrico para comparar la eficacia y la seguridad de QL1205 frente a Lucentis® en pacientes con degeneración macular neovascular asociada a la edad. (EUDRACT: 2018-004486-13). Grant by Qilu Pharmaceutical Co\n\n' Estudio NEUTON: Ensayo clinico en fase IV para evaluar la eficacia de aflibercept en pacientes Naive con Edema MacUlar secundario a Oclusion de Vena CenTral de la Retina (OVCR) en regimen de tratamientO iNdividualizado Treat and Extend (TAE)”, (2014-000975-21). Grant by Fundacion Retinaplus\n\n' Evaluación de la seguridad y bioactividad de anillos de tensión capsular en conejo. Proyecto Procusens. Grant by AJL, S.A.\n\n'Estudio epidemiológico, prospectivo, multicéntrico y abierto\\npara valorar la frecuencia de la conjuntivitis adenovírica diagnosticada mediante el test AdenoPlus®\\nTest en pacientes enfermos de conjuntivitis aguda”\\n. National, multicenter study. Grant by: NICOX.\n\nEuropean multicentric trial: 'Evaluation of clinical outcomes following the use of Systane Hydration in patients with dry eye”. Study Phase 4. Grant by: Alcon Labs'\n\nVLPs Injection and Activation in a Rabbit Model of Uveal Melanoma. Grant by Aura Bioscience\n\nUpdating and characterization of a rabbit model of uveal melanoma. Grant by Aura Bioscience\n\nEnsayo clínico en fase IV para evaluar las variantes genéticas de la vía del VEGF como biomarcadores de eficacia del tratamiento con aflibercept en pacientes con degeneración macular asociada a la edad (DMAE) neovascular. Estudio BIOIMAGE. IMO-AFLI-2013-01\n\nEstudio In-Eye:Ensayo clínico en fase IV, abierto, aleatorizado, de 2 brazos,\nmulticçentrico y de 12 meses de duración, para evaluar la eficacia y seguridad de un régimen de PRN flexible individualizado de 'esperar y extender' versus un régimen PRN según criterios de estabilización mediante evaluaciones mensuales de inyecciones intravítreas de ranibizumab 0,5 mg en pacientes naive con neovascularización coriodea secunaria a la degeneración macular relacionada con la edad. CP: CRFB002AES03T\n\nTREND: Estudio Fase IIIb multicéntrico, randomizado, de 12 meses de\nseguimiento con evaluador de la agudeza visual enmascarado, para evaluar la eficacia y la seguridad de ranibizumab 0.5mg en un régimen de tratar y extender comparado con un régimen mensual, en pacientes con degeneración macular neovascular asociada a la edad. CP: CRFB002A2411 Código Eudra CT:\n2013-002626-23\n\n\n\nPublications\t\n\n2021\n\n\n\n\n2015\n\n\n\n\n2021\n\n\n\n\n\n2021\n\n\n\n\n2015\n\n\n\n\n2015\n\n\n2014\n\n\n\n\n2015-16\n\n\n\n2015\n\n\n2014\n\n\n2014\n\n\n\n\n2014\n\n\n\n\n\n\n\n2014\n\nJose Carlos Pastor; Jimena Rojas; Salvador Pastor-Idoate; Salvatore Di Lauro; Lucia Gonzalez-Buendia; Santiago Delgado-Tirado. Proliferative vitreoretinopathy: A new concept of disease pathogenesis and practical\nconsequences. Progress in Retinal and Eye Research. 51, pp. 125 - 155. 03/2016. DOI: 10.1016/j.preteyeres.2015.07.005\n\n\nLabrador-Velandia S; Alonso-Alonso ML; Di Lauro S; García-Gutierrez MT; Srivastava GK; Pastor JC; Fernandez-Bueno I. Mesenchymal stem cells provide paracrine neuroprotective resources that delay degeneration of co-cultured organotypic neuroretinal cultures.Experimental Eye Research. 185, 17/05/2019. DOI: 10.1016/j.exer.2019.05.011\n\nSalvatore Di Lauro; Maria Teresa Garcia Gutierrez; Ivan Fernandez Bueno. Quantification of pigment epithelium-derived factor (PEDF) in an ex vivo coculture of retinal pigment epithelium cells and neuroretina.\nJournal of Allbiosolution. 2019. ISSN 2605-3535\n\nSonia Labrador Velandia; Salvatore Di Lauro; Alonso-Alonso ML; Tabera Bartolomé S; Srivastava GK; Pastor JC; Fernandez-Bueno I. Biocompatibility of intravitreal injection of human mesenchymal stem cells in immunocompetent rabbits. Graefe's archive for clinical and experimental ophthalmology. 256 - 1, pp. 125 - 134. 01/2018. DOI: 10.1007/s00417-017-3842-3\n\n\nSalvatore Di Lauro, David Rodriguez-Crespo, Manuel J Gayoso, Maria T Garcia-Gutierrez, J Carlos Pastor, Girish K Srivastava, Ivan Fernandez-Bueno. A novel coculture model of porcine central neuroretina explants and retinal pigment epithelium cells. Molecular Vision. 2016 - 22, pp. 243 - 253. 01/2016.\n\nSalvatore Di Lauro. Classifications for Proliferative Vitreoretinopathy ({PVR}): An Analysis of Their Use in Publications over the Last 15 Years. Journal of Ophthalmology. 2016, pp. 1 - 6. 01/2016. DOI: 10.1155/2016/7807596\n\nSalvatore Di Lauro; Rosa Maria Coco; Rosa Maria Sanabria; Enrique Rodriguez de la Rua; Jose Carlos Pastor. Loss of Visual Acuity after Successful Surgery for Macula-On Rhegmatogenous Retinal Detachment in a Prospective Multicentre Study. Journal of Ophthalmology. 2015:821864, 2015. DOI: 10.1155/2015/821864\n\nIvan Fernandez-Bueno; Salvatore Di Lauro; Ivan Alvarez; Jose Carlos Lopez; Maria Teresa Garcia-Gutierrez; Itziar Fernandez; Eva Larra; Jose Carlos Pastor. Safety and Biocompatibility of a New High-Density Polyethylene-Based\nSpherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits. Journal of Ophthalmology. 2015:904096, 2015. DOI: 10.1155/2015/904096\n\nPastor JC; Pastor-Idoate S; Rodríguez-Hernandez I; Rojas J; Fernandez I; Gonzalez-Buendia L; Di Lauro S; Gonzalez-Sarmiento R. Genetics of PVR and RD. Ophthalmologica. 232 - Suppl 1, pp. 28 - 29. 2014\n\nRodriguez-Crespo D; Di Lauro S; Singh AK; Garcia-Gutierrez MT; Garrosa M; Pastor JC; Fernandez-Bueno I; Srivastava GK. Triple-layered mixed co-culture model of RPE cells with neuroretina for evaluating the neuroprotective effects of adipose-MSCs. Cell Tissue Res. 358 - 3, pp. 705 - 716. 2014.\nDOI: 10.1007/s00441-014-1987-5\n\nCarlo De Werra; Salvatore Condurro; Salvatore Tramontano; Mario Perone; Ivana Donzelli; Salvatore Di Lauro; Massimo Di Giuseppe; Rosa Di Micco; Annalisa Pascariello; Antonio Pastore; Giorgio Diamantis; Giuseppe Galloro. Hydatid disease of the liver: thirty years of surgical experience.Chirurgia italiana. 59 - 5, pp. 611 - 636.\n(Italia): 2007. ISSN 0009-4773\n\nChapters in books\n\t\n' Salvador Pastor Idoate; Salvatore Di Lauro; Jose Carlos Pastor Jimeno. PVR: Pathogenesis, Histopathology and Classification. Proliferative Vitreoretinopathy with Small Gauge Vitrectomy. Springer, 2018. ISBN 978-3-319-78445-8\nDOI: 10.1007/978-3-319-78446-5_2. \n\n' Salvatore Di Lauro; Maria Isabel Lopez Galvez. Quistes vítreos en una mujer joven. Problemas diagnósticos en patología retinocoroidea. Sociedad Española de Retina-Vitreo. 2018.\n\n' Salvatore Di Lauro; Salvador Pastor Idoate; Jose Carlos Pastor Jimeno. iOCT in PVR management. OCT Applications in Opthalmology. pp. 1 - 8. INTECH, 2018. DOI: 10.5772/intechopen.78774.\n\n' Rosa Coco Martin; Salvatore Di Lauro; Salvador Pastor Idoate; Jose Carlos Pastor. amponadores, manipuladores y tinciones en la cirugía del traumatismo ocular.Trauma Ocular. Ponencia de la SEO 2018..\n\n' LOPEZ GALVEZ; DI LAURO; CRESPO. OCT angiografia y complicaciones retinianas de la diabetes. PONENCIA SEO 2021, CAPITULO 20. (España): 2021.\n\n' Múltiples desprendimientos neurosensoriales bilaterales en paciente joven. Enfermedades Degenerativas De Retina Y Coroides. SERV 04/2016. \n' González-Buendía L; Di Lauro S; Pastor-Idoate S; Pastor Jimeno JC. Vitreorretinopatía proliferante (VRP) e inflamación: LA INFLAMACIÓN in «INMUNOMODULADORES Y ANTIINFLAMATORIOS: MÁS ALLÁ DE LOS CORTICOIDES. 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