Clinical Trial Regulatory Services in Africa
Adherence to clinical trial regulations is crucial for ensuring
participant safety, increasing transparency of your trial, and
maintaining data quality.
Although the African regulatory landscape may seem daunting to
international sponsors interested in conducting clinical
research on the continent, Infiuss Health will ensure that your
clinical studies are conducted in compliance with rules set by
national authorities and international GCP standards.
How Are Clinical Trials Regulated?
Clinical trial regulations are established by national competent
authorities. Regulations exist to ensure the safety of
participants during the research process and promote increased
transparency between participants and trial organizers.
These regulations are followed by all clinical trial stakeholders,
including sponsors, CROs, and all healthcare professionals working
on the trial.
What Are Regulatory Authorities in Clinical Trials?
Regulatory authorities in clinical trials are governmental or state-owned organizations that set safety, technical, and quality standards for trials conducted in a certain country.
The Food and Drug Administration (FDA) is the regulatory authority for the US. Some other regulatory authorities include the European Medicines Agency (EMEA) in the European Union, the Medicines & Health Regulatory Agency (MHRA) for the United Kingdom, and the African Medicines Agency (AMA) across Africa.
In Africa, each nation has its own regulatory body. Here are some examples:
The South African Health Products Regulatory Authority (SAHPRA) oversees clinical regulations in South Africa
The Pharmacy Board of Sierra Leone (PBSL) is the organization responsible for regulatory oversight in Sierra Leone clinical research
The Pharmacy and Poisons Board (PPB) has regulatory oversight of clinical research in Kenya
The Liberia Medicines and Health Products Regulatory Authority (LMHRA) oversees clinical compliance in Liberia
The National Drug Authority (NDA) is in charge of regulatory compliance in Uganda
The Food and Drug Authority (FDA) is in charge of clinical trial regulatory compliance in Ghana
The National Agency for Food & Drug Administration & Control (NAFDAC) is in charge of regulatory compliance in Nigeria.
What Is Regulatory Compliance in Clinical Research?
Regulatory compliance in clinical research describes the requirement for organizations conducting clinical research companies to follow federal regulations when conducting research.
Federal regulations require the appropriate conduct of clinical
trial research and ensure rigorous trial monitoring and human
subject research participant protection.
Infiuss Health
conducts research in compliance with the regulations and rules set
by the United States FDA, GCP regulations, as well as the African
Medicines Agency. When conducting clinical research across Africa,
we do so in full compliance with the relevant national regulatory
body.
Why Are Clinical Trial Regulations Important?
Clinical trial regulations are important to ensure all clinical
trials are following the necessary rules to protect both the
participants and the trial data.
There are three main goals of trial regulation:
participant protection (protecting rights, safety, and wellbeing of research participants)
data protection (ensuring standards for quality clinical trial data, including specimen collection, are adhered to)
harmonizing regulatory processes (thereby simplifying the trial process)
Why Conduct Clinical Trials in Africa?
A technology-first approach to research. We are your foot on the ground in Africa.
Access
Traditionally, Africa has not been particularly accessible to American and European researchers. We’re changing that, with the provision of quality clinical research for easy access to African research sites and participants.
Cost
Our pharmaceutical & academic partners conduct clinical trials in Africa for a fraction of the cost they would spend in other geographic regions.
Genetic Diversity
The African population exhibits greater genetic diversity than the rest of the world combined. Obtaining safety and efficacy data in clinical trials from populations with broader genetic diversity is essential for data integrity and generalizable results.
Endemic Diseases
If you’re researching rare diseases endemic to the African continent (e.g., malaria, ebola, sickle cell anemia, hantavirus or monkeypox), you’ll want to conduct your clinical trials in Africa.
What Are GCP Regulations?
Good Clinical Practice (GCP) regulations are a set of internationally recognized, scientific, quality and ethical requirements that must be followed when conducting, recording, and reporting clinical research that involves human participants These regulations are followed internationally, regardless of the governing national regulatory authorities.
What Are the Main GCP Principles?
There are thirteen GCP principles that must be followed in any human trial:
- Ethics: all clinical trials should be conducted in accordance with ethical principles consistent with GCP and the applicable regulatory requirements.
- Trial Participants: The rights, well-being, and safety of the trial participants must prevail over the interests of science and society.
- Trial Risk vs Benefit: Foreseeable inconveniences and risks must be weighed against the anticipated benefits for trial subjects and society. A trial should be initiated only when the benefits justify the risks.
- Medicinal Product Information: available clinical and non-clinical information on the investigated medicinal product should support the proposed trial.
- Study Protocol Compliance: The trial should be done in compliance with protocols set by ethics committees and institutional review boards.
- Good Quality Trials: The trial should be scientifically sound and described in a detailed, clear protocol.
- Medical Decisions: The medical care given to and made on the behalf of subjects should always be the responsibility of a qualified healthcare professional.
- Informed Consent: Freely given informed consent, as well as consent to share personal data and information, must be obtained from every subject before they participate in the trial.
- Trial Staff: All individuals involved in conducting the trial must be educated and qualified to perform their respective tasks.
- Confidentiality: Records that could identify participants must be protected in accordance with the applicable regulatory requirements.
- Clinical Trial Data: Clinical data information must be recorded, stored, and handled by a qualified data manager in a way that ensures data protection and accuracy in reporting, verification, and interpretation.
- Good Manufacturing Practice: The investigational product should be manufactured, stored, and handled in accordance with the GMP.
- Quality Assurance: Systems with procedures that ensure the quality of the trial must be implemented and followed.
How Are Clinical Trials Regulated?
Clinical trial regulations are established by national competent
authorities. Regulations exist to ensure the safety of
participants during the research process and promote increased
transparency between participants and trial organizers.
These regulations are followed by all clinical trial stakeholders,
including sponsors, CROs, and all healthcare professionals working
on the trial.
Types of Clinical Trials
Based on trial location, the three main types of clinical trials are centralized, hybrid, and decentralized trials. Each of these three types can consist of the following clinical trial applications:
Pilot and feasibility trials
Interventional trials
Prevention trials
Screening trials
Case-control trials
Cohort trials
Cross-sectional trials
Multi-arm, multi-stage (MAMS) trials
Infiuss is a CRO with experience in running a variety of clinical studies across Africa. We help you recruit patients for centralized, hybrid, or decentralized trials. We can assist with selecting a suitable site for centralized trials, collecting and managing data, and ensuring that your trial goes smoothly from study design to study close-out.
Medical Devices
Africa is a great place to conduct clinical trials if you’re developing a medical device. Think of us as your CRO partner for every aspect of your medical device clinical trial.
Drug Development
Infiuss Health is the preferred CRO in Africa for pharmaceutical companies. With our concierge services and Probe CDMS, we handle everything from site selection to clinical study reporting.
Clinical Researchers
From the biopharmaceutical industry to academia, clinical researchers of all types choose Infiuss Health as their CRO partner to manage clinical trials in Africa.
Frequently Asked Questions on Clinical Regulations
Beyond specimen collection, Infiuss is your African CRO partner for all clinical trial needs. From patient recruitment to clinical data management, pharmacovigilance to site management, we will partner with you for all types of clinical research.
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