Drug discovery and VDDCs

Introduction: Contract Research Organizations (CROs), Clinical Research Centers/Networks and private research institutions play an important role in the clinical research process, especially in the drug discovery and development process. They act as essential partners for pharmaceutical drug delivery/development and biotech companies. Over the last few decades, the demand for outsourcing of clinical research by pharmaceutical companies has increased, with the market for CRO and private research institutional services growing significantly. This trend has been driven by a need for increased productivity and efficiency to meet the increasing research and development costs, as well as the complexities associated with modern drug development. Statement of objective: This study has an objective to establish CROs with known recognition in sub Saharan Africa. Special emphasis on Cameroon institutions regulating and conduct clinical research. Methodology: Historically, drug discovery services were predominantly conducted in-house, safeguarding intellectual property and close collaboration with internal teams. However, the competitive nature of the sector has motivated pharmaceutical companies to adopt an outsourcing model, allowing them to decentralize, outsourced and exploit specialized expertise and technologies offered by the CROs. These partnerships enable drug developers to accelerate the identification and validation of promising drug candidates through streamlined pre-clinical and clinical trial processes. This is systematic research findings that we conducted a systematic search of the source documents from organizations, access to websites and google search to assemble our information, e-data information system. The systematic search gave us information on the contract organizations with online visibility. Vital information from annual reports, web information system management of the different organizations were accessible for easy navigations. Information on laws governing clinical research and major regulators in Cameroon. Results: Through a systematic online search contract research organization operating in Cameroon and Sub Saharan Africa that were available and accessible on line were identified. The list was not exhaustive as some CROs may be in existence but we could not have access to their activities and home page for enough visibility online. The organizations and CROs operating in Cameroon have been well illustrated. The laws and regulations governing clinical research in Cameroon has been well illustrated. It was observed that CROs face multiple challenges. The Contract Research Organization (CRO) are faced with multiple challenges that can be a limiting factor to their growth and quality service delivery: These challenges are listed though not exhaustive as Technological Disruption, Regulatory landscape, intellectual Property Issues, Economic Volatility, Limited Human resource expertise, Return on investment/High Costs: Conclusion/Recommendation: The CROs in Cameroon are required to be in compliance with the law regulating research in human subjects of 2022 and the regulations on Clinical research in Cameroon. In sub Saharan Africa CROs are aligned with the regulation enforced in their different countries. The success of CROs is based on their compliance to innovative trends in clinical research and the capacity to strengthen collaboration among policy makers and actors. The ability to face challenging opportunities in clinical research and embrace transformative breakthroughs that can bring faster new chemical entities to the market at the same time improving the standard of care (SOC) of the population. In the future, the synergy between innovation, strategic partnerships, and a commitment to excellence for CROs shall be the cornerstones of future success in conducting clinical research for Pharmaceutical drug discovery and development Based on the regulatory demanding nature of clinical regulation in Cameroon CROs must have a legal jurisdiction and recognition of their operation, and conform to the norms and standard laid down by regulatory authorities and the states of their jurisdiction CROs offer a wide range of services to support the development and execution of clinical trials, ensuring compliance with regulatory requirements and ethical standards. Clinical Research Organizations (CROs) play a pivotal role in the pharmaceutical, biotechnology, and medical device industries as a research service delivery provider on a contract basis.

Background Over the last year, the bioanalytical community strongly expressed their need for international harmonization of bioanalytical guidances through numerous international meetings and publications, and this need was acknowledged by several regulatory agencies [1–5]. Following the 4th Calibration and Validation Group (CVG) Workshop on Regulated Bioana lysis hosted in Montreal (April 2010), a unanimous consensus was reached for the global bioanalytical community to identify non-prescriptive, s ciencebased language that could form the basis of a proposed guidance document on bioana lysis [6]. Ideally, such guidance language would describe the rationale behind each bioanalytical requirement and would be presented for consideration by agencies and industry worldwide. A recent concrete action taken towards such global harmonization of bioanalytical guidances was the creation of the Global Bioana lysis Consortium (GBC). Drawing from representatives of scientific associations with involvement in regulated bioana lysis across the globe, the objective of the GBC is to merge existing or emerging bioanalytical guidances and create a unified document that can be presented to the regulatory authorities in various countries and regions. The development of the GBC is currently in process, with the intention to present plans and updates at upcoming bioanalytical meetings and to seek input from the scientists conducting bioana lysis [7]. At the 4th CVG Bioana lysis Workshop in Montreal, Canada, several Contract Research Organizations (CROs) highlighted the importance of having a strong and cohesive CRO contribution to the global harmonization process. Having CROs, academic laboratories and pharma ceutical industries appropriately represented was viewed as critical to identifying optimum language. Consequently, the proposal to build a Global CRO Council (GCC) arose, designed to be a distinct group consisting exclusively of bioanalytical CRO members conducting r egulated bioana lysis business. To initiate creation of the GCC, a special closed forum was held in Montreal on 14 September 2010, where 41 executive representatives from 32 bioanalytical CROs were present to discuss scientific harmonization issues and the institution of the GCC. This first CRO Formation of a Global Contract Research Organization Council for Bioana lysis

Roles of contract research organizations in translational medicine

This paper studies inventory share policies for sustainable omni-channel e-commerce supply network design by seeking for a good integration policy of online and offline retailers so that the overall supply network reduce its cost, environmental negative impacts by the decreased number of shipments from the main depot, and increase its responsiveness. By the recent advancement in information technologies and internet use, e-commerce practice gained popularity also to keep up with the competitive environment. The increased competitive supply chain environment has revealed the business-to-business (B2B) concepts enabling business applications between companies. Strategic alliance is a partnership concept realized between two or more organizations ensuring that stages are managed with consideration of the welfare of the others in the whole network. By considering that there are inventory share policies between stages, we accept the existence of strategic alliance implementation in the network, aiming to increase total network flexibility and profitability as well as sustainability in the network. In the study, we research inventory share policies towards strategic alliance concept to have a network design with a decreased negative effect of demand uncertainty and increased profitability in the network. By inventory share policies, businesses share their current inventories with the others so that transportation cost and CO2 emission caused by traffic intensity is decreased in the network. We propose six inventory share policy combinations and optimize the (s, S) inventory levels under those policies by minimizing total network cost. We utilize the simulation modeling approach for the modeling purpose. We compare the policy results based on the total network cost, the total number of shipments completed from the main warehouse, and total lost sale cost, etc., at the optimal levels and suggest the best policy design.

With the growing research on deviance, researchers have increasingly identified the two forms of deviance (i.e., positive and negative workplace deviance). In today's competitive environment, organizations must strive to balance these two types of deviance to find their sustainability. Today's cutthroat business environment demands a workplace that encourages employees to be creative and find new ways to work harder and smarter. Ethical leaders play a motivational inspiration for their co-subordinates, allowing them to be positively deviant and try to make processes better and more efficient. But it is not always easy to maintain such a positive environment within the organization as some employees may misuse this freedom and even harm the organization or its people. With the changing generations, today's young mind, (i.e., millennials) consider the positive and healthy competition which boosts their productivity. Thus, managing workplace wellness is part of the sustainable workplace environment.

Today, international competition is growing rapidly, and enterprises must always remain ahead of the competition to ensure their survival. Therefore, firms must keep pace with dynamic conditions and rapid changes, be innovative, and adapt to new systems, techniques and technologies. In a competitive market environment, customers are becoming more conscious and tend to demand a particular number of customised products at a particular speed. Furthermore, fluctuations in national economies and in the global economy create significant risks. Because of all of these factors in today's competitive environment, firms have begun to make radical changes in their management and production structures. They must also reduce costs to maintain their current position in the market.

General aspects of bioanalytical (BA) outsourcing, such as: history and current outsourcing strategies; advantages, disadvantages and challenges; factors influencing contract research organization (CRO) selection; different models of contractor and CRO relationships; cost management in a CRO; and the future and perspectives of outsourcing have been discussed before [1,2]. At the 20th International Reid Bioanalytical Forum, a full session was dedicated to “collaborative partnerships between CROs and pharmaceutical companies” [3], demonstrating the increased importance of outsourcing to the pharmaceutical industry, which is experiencing probably the most turbulent time in its history due to continuous increase of drug-development costs, while blockbusters are running out of patents and fewer novel drug candidates gain regulatory approval. Neil Spooner (GlaxoSmithKline, Hertfordshire, UK) reported in his talk at the Reid Forum, that at GlaxoSmithKline, BA outsourcing had grown from approximately 30% in September 2010 to nearly 75% in March 2012, while toxicokinetics outsourcing rose from approximately 11 to 28% in the same period [3]. When talking about outsourcing in bioanalysis, one usually means regulatory bioanalysis; however, outsourcing even of discovery bioanalysis in the drug discovery stage has started. Graeme Clark (Cyprotex, Macclesfield, UK) illustrated at the Reid forum, by using real examples, the risk of wrong analytical results, since at this early stage usually no structural information on the analyte is provided to the CRO [3]. For the time being, it remains open if outsourcing of exploratory bioanalysis becomes a success story. This article presents a personal perspective on BA outsourcing strategies with a focus on differences, benefits and challenges of BA outsourcing to local (national) versus international CROs.

Today, pharmaceutical companies aim to speed up the time it takes for drugs to reach the market at minimal cost, increasingly collaborating with contract research organizations (CROs) in all areas, from study design and patient recruitment to regulatory submissions and data management. The aim of this article is to summarize and systematize the stages of development of clinical outsourcing models based on a study of the characteristics of the global CRO market. The article explains the essence of CROs and clinical research sites (CRSs). The factors driving the growth of the global CRO market have been identified: increased research and development funding, a rise in the number of clinical trials, and the expiration of patents for well-known drugs. The phases of clinical trials are analyzed in terms of content, number of participants, duration, cost, and success rate. The risks of clinical trials have been identified, including: significant cost, high dropout rate, considerable duration, and complexity of regulatory acts. Regional features of conducting clinical trials have been considered. The top 10 leaders in the global CRO market in 2024 have been characterized. Models of cooperation between CROs and sponsors have been summarized. The advantages, disadvantages, and examples of applying existing clinical outsourcing models have been determined. The stages of development of clinical outsourcing models have been systematized: from targeted outsourcing to strategic partnership and transformational outsourcing. Current directions for improving CRO activities have been determined. The goal of further research in this direction should be to explore ways to expand cooperation between CROs and leading IT companies regarding the implementation of digital health technologies in working with clinical trial participants and artificial intelligence for managing data during its course.

BACKGROUND: Platelet Inhibition and Clinical Outcomes (PLATO) was a multicenter, randomized double-blind trial assessing efficacy and safety of ticagrelor versus clopidogrel in patients with acute coronary syndrome. The reported mortality benefit of ticagrelor in the PLATO trial has been challenged for over decade, and never confirmed in later trials.OBJECTIVE: To compare if there were any differences when deaths were reported to the FDAby the sponsors or by independent Contract Research Organizations (CRO).METHODS: We obtained the complete PLATO deaths dataset reported to the FDA and revealed that some events were inaccurately reported favoring ticagrelor. The entire FDA list contains precisely detailed 938 PLATO deaths. The CRO reported outcomes from the USA, Russia, Georgia, and most of Ukraine, while sites in 39 other countries were controlled by the trial sponsors. We compared vascular- (code “11”), non-vascular- (code “12”), and unknown (code “97”) deaths triaged by the reporting source.RESULTS: Overall, most PLATO deaths were vascular (n=677), less non-vascular (n=159) andunexpectedly many of “other” (n=7) or “unknown” (n=95) origin reported either by sponsors (n=807) or CRO (n=131). The trial sponsors reported more clopidogrel deaths from vascular (313 vs.239), non-vascular (86 vs.58) and unknown (53 vs. 26) causes.In contrast, CRO-monitored sites reported significantly (72 vs. 53; p<0.01) more ticagrelordeaths than after clopidogrel from vascular (51 vs.39), non-vascular (8 vs.7) and unknown (10 vs. 4) causes.CONCLUSION: Deaths were reported differently by sponsors and CRO within the same trial. Since some deaths were misreported by PLATO sponsors, only the CRO data seems mostly reliable. Among all countries, the CRO - reported PLATO-USA outcomes represent the largest and most realistic dataset of realistic evidence suggesting ticagrelor inferiority to clopidogrel for all primary endpoint components including vascular death.

Contract research organizations (CROs) have a key role in drug discovery and development, but processes for evaluating, engaging and managing CRO contracts may not be well established in academic institutions or small companies. Here, we recommend an approach to optimize the execution of drug discovery programmes in such environments.

Contract research organizations (CROs) handle an increasing amount of clinical research for pharmaceutical companies. By contracting work to an outside organization, sponsors relinquish some control of the conduct of theirstudies. It is incumbent on both the CRO and the sponsor to communicate effectively in order to ensure the quality of the research. Communication begins during contract negotiations, and carries through in the day-to-day collaboration as the study proceeds. As one assessment of the quality of the collaboration, Quintiles Transnational Corp., a CRO, conducts telephone surveys of its client companies. The survey questions are primarily open-ended, and interviews last 10-15 minutes. Results of the surveys are summarized in a matrix format: general issues such as training and resources are reported to management; project-specific findings are reported to the project manager. Positive and negative comments are reported, and the importance of continuous improvement is emphasized. The sampling technique, preparation, format, and examples of findings will be described. Although systematic client interviews are not traditional components of quality assurance (QA), their role in quality management can be helpful to CROs that want a comprehensive approach to client satisfaction. The advantages and potential drawbacks of the surveys in terms of client expectation and staff motivation will be discussed.

1. A questionnaire, prepared to define the profile of the clinical monitor, was sent to pharmaceutical companies and contract research organisations (CROs) in Italy. Out of 70 organisations contacted, 51 questionnaires (71%) were returned by the end of 1997. 2. The sample size was 434 clinical monitors, of which most (94.7%) were graduates in biology, pharmacy or medicine. The profile, as defined in the ICH-4, was met in 60%. 3. All received basic training on Good Clinical Practice (GCP), half through in-house courses. Only 5% of the pharmaceutical companies provided additional training on specific scientific aspects of the clinical protocols. 4. Overall 44% were based in the field but this percentage was 77.8% when only the CROs were considered. For the pharmaceutical companies, the workload was calculated according to the number of investigational sites to be monitored (mean, 10 sites), while the number of visits per month was preferred by the CROs. 5. The monitoring activity was always performed in accordance with proper standard operating procedures. 6. The profile of the clinical monitor in Italy fits the international requirements, despite some differences between pharmaceutical companies and CROs.

Europe's drug industry is going through an efficiency drive to cut costs, raise productivity, and focus on more profitable therapeutic areas. Research chemists and other scientists face the prospect of losing their jobs as staff numbers are reduced. Whole research units are being closed or transferred to new owners that want to economize with fewer employees. But researchers have a reasonable prospect of finding work in an R&D sector that is no longer dominated by pharmaceutical multinationals. In addition to drug discovery start-ups, new jobs can be found in the growing collection of contract research organizations (CROs) serving the discovery and preclinical stages of research. These CROs earn their revenue by providing a range of support services to both big and small companies at the leading edge of drug technology. Many CRO research staffers are former employees of big pharma companies where the priority is no longer the in-house discovery

Collaborations between the pharmaceutical industry and contract research organizations continue to represent an attractive alternative to internal drug discovery within a single organization. This Viewpoint covers many of the business models and strategies that are employed in industry-contract research organization collaborations.

Service quality is very important for practitioners in service organization in order to success and survival in today's competitive environment. Indentifying the dimensions of the service quality would definitely help managers in the challenge of improving the service quality. Service-quality evaluation is usually fuzzy because of the process concerning human being's subjective judgment. This study presents an evaluation approach to evaluate the consistency of service quality problem with fuzzy numbers. Based on the probability of fuzzy sets defined by Zadeh [1], the membership function of triangular fuzzy number determined by each customer with respect to each evaluation-item is first calculated, the coefficient of variation is calculated, and the degree of service consistency for each evaluation-item can then be recognized. Those data can be the bases when making strategies of improving service quality. An empirical study is conducted to illustrate the effectiveness of the presented approach.