Clinical Trials Adverse Event Management

At Dr. Mwiko Health Solutions Ltd, we recognize that clinical trials form the cornerstone of drug development, providing critical insights into the safety and efficacy of investigational products.

We support sponsors and clinical research organizations (CROs) throughout all stages of clinical development from early-phase studies to post-marketing trials ensuring robust safety oversight and full regulatory compliance.

Our Clinical Trial Safety Services Include:

Operational Safety Activities

• Adverse Event (AE) and Serious Adverse Event (SAE) processing, including pregnancies and AESIs
• Data entry, coding, narrative writing, and quality control in validated safety systems
• Expectedness assessments, unblinding, and case reconciliations across multiple data sources
• Safety report submissions (e.g., SUSARs, DSURs, IND Annual Safety Reports) to regulatory authorities, ethics committees, and investigators in full compliance with global and local timelines

Safety Writing & Reporting

• Preparation of Development Safety Update Reports (DSURs), line listings, and aggregate safety summaries
• Medical review and quality assurance by experienced safety physicians and scientific writers

Why Partner with Dr. Mwiko Health Solutions Ltd

With our regional expertise, global standards, and integrated partner network, we are equipped to manage clinical trial pharmacovigilance activities across Africa and internationally.

Whether you are a sponsor, CRO, or academic institution, our clinical trial safety solutions are flexible, scalable, and designed to align perfectly with your development program.