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 their requirements in terms of investigator expertise, patient access, data quality, budget, and timelines. We understand the structural complexity of healthcare systems in Africa while maintaining global GCP standards throughout the selection process.
- 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 clinical trial may commence, approval is required from both the ethics committee and the competent authority — two distinct review bodies with independent review processes. THESYL coordinates both processes — managing documentation, responding to queries, and maintaining timelines across both review 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
Recognising the pivotal role sites play in clinical study success — and the pressures facing healthcare staff in African hospitals and health facilities — we build strong, trust-based partnerships with each site we work with. Our site management approach combines comprehensive documentation support with continuous regulatory compliance oversight, easing the operational burden on site teams without compromising 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 (CRAs) work closely with sites to ensure patient recruitment milestones are met and data quality is maintained throughout the study. We offer monitoring models tailored to site capability, trial risk profile, and sponsor requirements — from full on-site monitoring to risk-based remote approaches suited to sites where in-person access is resource-intensive.
- 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 provides end-to-end bioavailability/bioequivalence (BA/BE) study services supporting generic manufacturers registering products across African markets — delivering the audit-ready evidence competent authorities require.
- 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's Clinical Project Managers (CPMs) oversee the entire lifecycle of clinical trials — initiating, planning, executing, monitoring, and closing projects while ensuring adherence to timelines, quality standards, and regulatory and ethics requirements. Our project management approach integrates proactive risk management and regular communication with sponsors and partners at every stage, so potential challenges are identified early, and data integrity is maintained throughout.
- 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 regulatory staff and clinical professionals to produce a wide range of trial documents and reports tailored to client specifications and national regulatory authority submission requirements. We produce documents aligned to ICH standards, ensuring that study documentation meets the quality bar expected by regulatory authorities and sponsors.
- 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 — SAE and SUSAR management, expedited reporting to regulatory authorities and ethics committees, MedDRA coding, and Development Safety Update Reports (DSURs).