Pharmacovigilance for African Clinical Trials
The safety and well-being of the patient is paramount throughout a drug's life-cycle, from drug-development to post-marketing authorization (Phase 1-4 studies). Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
Our suite of pharmacovigilance services delivers adequate safety reporting, thereby ensuring regulatory compliance and patient safety throughout the whole clinical trial process.
Drug Safety and Pharmacovigilance Services
With quality-driven, well-thought out processes, and comprehensive solutions, we offer the active management of drug safety and pharmacovigilance services, which can be uniquely tailored to fit your requirements. If you’re conducting drug development in Africa, you need a pharmacovigilance service provider versed in regulatory requirements and safety reporting requirements.
We have experience in a wide range of therapy areas including oncology, infectious diseases, and pediatric and maternal health, and provide support to clients with products already authorized or under development.
What is Included in Pharmacovigilance?
Our clinical pharmacovigilance services encompass every aspect of the clinical research and drug development lifecycle, and include
- Development of risk management plans
- Auditing services
- Development of standard operating procedures
- Clinical trial case processing
- Post-marketing case processing
- Validated safety databases
- Report writing
- Literature searches
- Regulatory reporting
Our Pharmacovigilance Service Offerings
Our suite of pharmacovigilance services delivers adequate safety reporting, thereby ensuring regulatory compliance and patient safety throughout the whole clinical trial process.
SMP Development
Pharmacovigilance starts with a good risk management plan. The Safety Management Plan (SMP) is a critical document for your clinical research. The SMP details all processes, timelines, and responsibilities for safety functions related to your trial. We take a systematic approach to safety management and SMP development so that risks are safely mitigated through the entirety of the product lifecycle.
Signal Management
Signal management is an important part of pharmacovigilance. Timely detection of potential pharmaceutical risks allows you to stay ahead of the curve with your product development. With our regulatory and industry experience in drug development, we take a systematic approach to signal management, including signal detection, signal validation, signal prioritization, and signal assessment.
Pharmacovigilance Auditing
A pharmacovigilance audit verifies the effectiveness and appropriateness of a pharmacovigilance system and is an essential component of your quality management system. Our pharmacovigilance auditing services meet and exceed Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP) standards.
Serious Adverse Event Reporting
Timely and efficient case processing and reporting of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) is paramount to maintaining the integrity of your clinical research. We help you design and implement systems that follow regulatory guidelines, including ICH E2D guidelines, for managing and reporting all types of adverse events.
Medical Monitoring Services
Monitoring plays an important role in the quality management of a clinical trial, as it ensures that the trial meets the highest international quality management standards. We are your clinical trial monitoring partner to ensure clinical safety for participants, as well as compliance with protocol. We have an experienced team of medical doctors who are responsible for SAE medical review, signaling, and review of development safety update reports.
Clinical Data Management
Capturing and managing clinical data accurately is crucial for research outcomes, as the subsequent data will form the basis of all efficacy and safety analyses. We can help with every aspect of your clinical data, from database design to case report form (CRF) design to electronic data capture, data validation, discrepancy management, data extraction, and database locking.
Why Do We Need Pharmacovigi-lance?
Pharmacovigilance is a drug safety and risk mitigation discipline that is essential to ensure patient safety in the development of new medicines. Rigorous testing and monitoring of new drugs helps improve the participant experience and reduces the risk of unwanted outcomes.
Postmarketing Pharmacovigilance Services
Infiuss is your African partner for postmarketing pharmacovigilance. From compiling and processing individual case safety reports (ICSR) to literature screening to safety database services, we understand go-to-market risk mitigation unlike other pharmacovigilance consulting providers.
Pharmacovigilance FAQ
Everything you need to know about pharmacovigilance and the service we offer. Can’t find the answer you’re looking for? Please chat to our team.
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.
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