Clinical Operations
End-to-end trial execution in Africa
01 - Feasibility and Site Selection
Finding the right site in the right market
We connect sponsors with experienced African sites that meet requirements for investigator expertise, patient access, data quality, budget, and timelines while maintaining global GCP standards.
- Site requirements and specifications
- Site and investigator identification across Africa
- Site feasibility assessment and evaluation
- Pre-study visits and screening visits
- Site selection and qualification
02 - Regulatory Submissions
Navigating regulatory authority and ethics committee requirements
Before a trial may commence, approvals are required from both ethics committees and competent authorities. THESYL coordinates both processes and maintains timelines across both tracks.
- Interpreting regulatory and ethics requirements
- Preparing clinical trial application packages
- Submissions to national competent authorities
- Submissions to national ethics committees
- Managing country-specific submissions across African markets
- Amendment and renewal submissions management
03 - Site Management
Supporting sites through every stage of the study
We build trust-based partnerships with each site and provide documentation, training, and compliance oversight to reduce site burden while preserving data quality.
- Inception and management of electronic Trial Master File
- EDC and eConsent provision through technology partners
- Site training and investigator support
- Patient enrolment, engagement, and retention support
- Site management documentation
- Regulatory compliance and protocol adherence oversight
- Regulatory authority inspection readiness
04 - Clinical Monitoring
Quality and enrolment performance at every visit
Our Clinical Research Associates work closely with sites to maintain recruitment performance and data quality across full on-site and risk-based remote models.
- Risk-based monitoring strategies
- Monitoring plan development and management
- Site visits
- Site initiation visits
- Interim(routine) monitoring visits
- Close-out visits
- Source data verification
- Remote and centralized monitoring
- ICH E6(R3) GCP compliance throughout
05 - Bioavailability and Bioequivalence Studies
From site assessment to regulatory submission, a single partner
THESYL delivers end-to-end BA and BE support for generic manufacturers, from feasibility and volunteer recruitment through pharmacokinetic evaluation and submission-ready reporting.
- Site assessment and qualification
- Study design and protocol development
- Regulatory and ethics submissions
- Volunteer recruitment, screening, and management
- Clinical conduct, dosing, and sample collection
- Pharmacokinetic and bioanalytical coordination
- Comparative statistical assessment
- Technical study reports and submission integration
06 - Project Management
Overseeing the full trial lifecycle
THESYL Clinical Project Managers oversee trial initiation, planning, execution, monitoring, and closeout while protecting timelines, quality, and compliance. We integrate risk management and regular sponsor communication at every stage.
- Comprehensive project planning and timeline management
- Regulatory and ethics approval coordination
- Site selection oversight and investigator meetings
- Budget management and resource allocation
- Risk identification and mitigation planning
- Stakeholder communication and reporting
- Trial closeout and final study report coordination
07 - Medical Writing
Documents that meet regulatory expectations
Our medical writing team collaborates with clinical and regulatory professionals to produce study documents aligned with ICH CTD structure and international regulatory standards.
- Common Technical Documents
- Study protocols and amendments
- Investigator Brochures
- Informed consent forms in English and French
- Development Safety Update Reports
- Clinical Study Reports
- Scientific publications and manuscripts
Languages
Many African research environments require trial documents in multiple languages. THESYL supports English, French, and local language adaptation where required.
Clinical Pharmacovigilance
All THESYL-managed clinical trials include clinical pharmacovigilance support including SAE and SUSAR handling, expedited reporting, MedDRA coding, and DSUR preparation.