A new chapter in clinical research is unfolding at Hôpital Principal de Dakar. Having never conducted a clinical trial before, the institution is taking important steps towards becoming a clinical research site. From 15 to 17 July 2026, Pharmalys delivered a comprehensive three-day training programme on Good Clinical Practice (GCP), in accordance with the ICH E6(R3) guideline, helping to build the foundation for future clinical research at the institution and strengthening research capacity in Senegal.
Under the theme “From Hospital to Clinical Trial Site”, this foundational certification programme was designed to equip hospital teams with the essential knowledge and practical skills required to prepare for and conduct clinical trials in accordance with international standards.
Delivered over 21 hours by Pharmalys trainers Assane and Aissatou, the programme brought together 24 healthcare professionals, including 7 physicians, pharmacists, nurses, biologists, laboratory technicians, data managers, administrative staff, quality managers and archivists. The participants gained a comprehensive understanding of Good Clinical Practice (GCP) principles and the key requirements for conducting ethical, compliant, and high quality clinical research.
Building clinical research capacity in Senegal
Africa remains underrepresented in international clinical trials, despite the growing need for diverse patient populations and research settings. At the same time, healthcare institutions that demonstrate strong governance, a robust quality culture, and expertise in Good Clinical Practice are becoming increasingly valued partners for sponsors and Contract Research Organisations (CROs).
As part of its commitment to advancing clinical research capabilities, Hôpital Principal de Dakar is taking important steps toward becoming an active clinical trial site. Having had no previous experience in conducting clinical trials, the hospital sought to build a solid foundation of knowledge among its multidisciplinary teams. The training programme was therefore designed to provide a practical and progressive introduction to conducting clinical trials while covering the key principles and requirements of the ICH E6(R3) guideline.
By strengthening participants’ understanding of clinical research processes, ethical considerations, quality requirements, and regulatory expectations, the programme aimed to lay the groundwork for future clinical trial activities. More broadly, it supports the hospital’s ambition to become a credible and capable clinical trial site, able to conduct clinical studies in line with international standards.
A practical introduction to ICH E6(R3)
Across the three days, the training combined interactive presentations with case studies, role-playing exercises, practical workshops, simulations and quizzes, allowing participants to explore both the theoretical and practical application of Good Clinical Practices.
The first day focused on the ethical and regulatory foundations of clinical research. Participants were introduced to the purpose and phases of clinical trials, as well as the broader clinical research landscape in Africa, with particular emphasis on emerging opportunities and Senegal’ s potential role within the ecosystem. The sessions also explored the historical foundations of research ethics, highlighting the key milestones and principles that have shaped modern clinical research and underpin the ICH E6(R3) Guideline for Good Clinical Practice.
Participants were then introduced to the core principles of ICH E6(R3), including the key enhancements and modernised concepts introduced by the revised guideline compared with ICH E6(R2). Through interactive discussions and practical examples, they explored how these principles support participant safety, data integrity, risk-based quality management, and proportionate oversight throughout the clinical trial lifecycle.
The day concluded with sessions on research ethics oversight and regulatory framework governing clinical trials in Senegal. Participants gained insight into the roles and responsibilities of ethics committees, as well as the national authorities involved in the review and authorisation of clinical research, including the Comite National d’Ethique pour la Recherche en Sante (CNERS) and the Agence de Régulation Pharmaceutique (ARP).
The second day focused on the practical implementation of a clinical trial. Sessions covered the roles and responsibilities of sponsors, investigators and site personnel highlighting the importance of collaboration, accountability, and effective oversight. Participants also explored how to establish a well-functioning study team, documentation of delegated responsibilities and ensure appropriate oversight and training.
The programme also covered two of the most important documents in clinical research: the protocol and the Investigator’s Brochure. Participants learned how to critically review these documents, assess study requirements, and evaluate the operational feasibility of a proposed trial within their institution. Through practical exercises, they gained insight into the factors that determine whether a site is adequately resourced and prepared to participate in a clinical study.
A simulated informed consent interview provided participants with an opportunity to apply Good Clinical Practice principles in a realistic setting. The exercise reinforced the concept of informed consent as an ongoing ethical process emphasising participant understanding, effective communication and voluntary decision-making rather than the simple completion of a consent form.
The day concluded with sessions on the management of investigational products and participant safety. Participants explored the responsibilities of pharmacists and site teams in the receipt, storage, dispensing, accountability, and documentation of investigational products. Training also covered pharmacovigilance requirements, including the identification, documentation, and reporting of adverse events (AEs) and serious adverse events (SAEs), underscoring the critical importance of participant safety throughout the conduct of a clinical trial.
Strengthening quality, data integrity and site readiness
The final day focused on data governance, quality assurance and quality control, reflecting the central role of data integrity in the generation of reliable, credible, and regulatory- compliant clinical research data.
Participants explored the distinction between source documents and electronic Case Report Forms (eCRFs), the principles of ALCOA++, confidentiality and data protection. The session also examined the management of computerised systems used in clinical research, including Electronic Data Capture (EDC) platforms, user access management, and audit trails, highlighting their importance in ensuring data traceability and integrity throughout the study lifecycle.
The training further addressed the management of essential clinical trial documentation, including the Investigator Site File (ISF), its relationship with the Trial Master File (TMF), and best practices for appropriate archiving and record retention. Participants gained a practical understanding of how accurate, complete, and well-maintained documentation supports regulatory compliance, inspection readiness, and the reconstruction of trial activities.
The final sessions introduced participants to monitoring, audits and regulatory inspections, providing an overview of the respective roles of Clinical Research Organisations and monitors in ensuring trial quality and oversight. Through practical examples, participants also explored the identification and management of protocol deviations, corrective and preventive actions and the key steps required to prepare a site for monitoring visits, audits and regulatory inspections.
Supporting sustainable clinical research capacity
Through these kind of initiatives, Pharmalys continues to support the development of clinical research expertise and strengthen the capacity of healthcare institutions across Senegal and the wider African region.
By equipping multidisciplinary hospital teams with a strong foundation in Good Clinical Practice, research ethics, data integrity, quality management, and regulatory compliance, the programme contributes to building the capabilities required to conduct clinical trials in accordance with international standards. Beyond individual knowledge transfer, such investments help establish the systems, processes, and quality culture needed to support sustainable clinical research growth.
Pharmalys remains committed to partnering with healthcare institutions, sponsors, and research stakeholders to build local expertise and support the development of trial-ready sites capable of delivering ethical, compliant, and high quality clinical research.
Is your Institution preparing to become a clinical trial site? Are you a sponsor or CRO seeking trial-ready research sites in Africa? Contact us today!
Find out more about Capacity Building at Pharmalys and our #CountAfricaIn initiative.
