Epicentre provides complete, end-to-end support for diagnostic and point-of-care evaluations.
Whether you require a comprehensive managed study or specific technical components, our team delivers high-quality, regulatory-compliant results that withstand international scrutiny.
1️⃣ Study Preparation & Regulatory Compliance
Ethics & Regulatory Submissions
Draft and submit complete study protocols to relevant South African ethics committees and SAHPRA (where applicable).
Track and manage all documentation until approval is obtained.
Maintain continuous compliance reporting during the study.
Protocol & SOP Development
Develop or adapt Standard Operating Procedures to align with WHO and GCP guidelines.
Write fit-for-purpose study protocols, participant information sheets, consent forms, and data collection tools.
Ensure traceability and reproducibility through version-controlled documentation.
Quality & Risk Management
Implement QA/QC frameworks to ensure accuracy and reproducibility.
Identify potential risks in field or lab procedures and design proactive mitigation plans.
🟩 Outcome: Fully approved, compliant study ready for implementation.
2️⃣ Participant Recruitment & Sample Collection
Participant Recruitment
Access to national participant networks across urban, peri-urban, and rural sites.
Tailored recruitment strategies to meet inclusion/exclusion criteria.
Informed consent processes are handled by trained, multilingual staff.
Sample Collection (Live & Retrospective)
Access to stored serum, plasma, swab, and urine samples via Epicentre’s biorepositories.
On-site collection through walk-in labs for live sample acquisition.
Strict temperature and transport control protocols are maintained.
Data Management During Recruitment
Use of encrypted digital tools for participant tracking and data capture.
Daily QA/QC reviews of demographic and sample information.
🟩 Outcome: Representative, ethically obtained samples ready for evaluation.
3️⃣ Testing & Laboratory Analysis
Reference Testing & Comparative Analysis
Conduct diagnostic testing under controlled conditions in our accredited partner laboratories.
Compare performance to gold-standard reference tests or comparator assays.
Generate sensitivity, specificity, and predictive value statistics.
Operational Feasibility Testing
Evaluate usability, device stability, and user performance under realistic field conditions.
Conduct time-to-result, error-rate, and environmental stress tests (temperature, humidity).
Quality Assurance Oversight
Adherence to Good Clinical Laboratory Practice (GCLP).
Independent monitoring and verification by internal QA officers.
🟩 Outcome: Comprehensive accuracy and usability data for your diagnostic device.
4️⃣ Data Management & Statistical Analysis
Data Capture & Monitoring
Electronic data collection using validated systems (REDCap, KoBoToolbox, or sponsor platforms).
Daily reconciliation between the lab, recruitment, and monitoring teams.
Secure backup and version tracking in accordance with data protection laws.
Statistical Analysis & Interpretation
Sensitivity/specificity, ROC curve analysis, and Cohen’s kappa agreement metrics.
Descriptive and inferential analysis with visual summaries.
Interpretation contextualised against local epidemiology and reference data.
Regulatory Reporting
Prepare analysis reports that meet WHO, FIND, and SAHPRA submission standards.
🟩 Outcome: Validated, submission-ready dataset and report package.
5️⃣ Archiving, Knowledge Transfer & Capacity Building
Epicentre ensures that every evaluation delivers lasting value — not only through high-quality results but also by strengthening local and international research capacity.
Our process emphasises secure data archiving, knowledge transfer, and team training to promote long-term impact.
Data Archiving & Documentation
Comprehensive digital and physical archiving of all project data, including consent forms, lab logs, and datasets.
Secure storage compliant with Good Clinical Practice (GCP) and Protection of Personal Information Act (POPIA) standards.
Metadata indexing for easy retrieval and regulatory audits.
Knowledge Transfer & Consultation
Structured knowledge-sharing sessions between Epicentre and client research teams.
Strategic handover of evaluation insights, operational lessons, and data-collection tools.
Tailored consultation for future diagnostic evaluations or public-health studies.
Training & Capacity Building
On-site and remote training for external evaluation teams to ensure consistent data-collection quality.
Hands-on mentoring in participant recruitment, sample management, and digital data capture.
Practical guidance on maintaining inter-rater reliability and QA/QC standards in field environments.
🟩 Outcome: Sustainable evaluation capacity across partner organisations and research sites, ensuring data accuracy, continuity, and long-term collaboration success.
6️⃣ Optional Support Services
Independent Monitoring & QA Audits: External verification of evaluation processes.
Study Site Setup: Infrastructure readiness checks, staff training, and logistics support.
Training Workshops: Capacity building on POC test evaluation, sample handling, and SOP adherence.
Stakeholder Presentations: Tailored results presentations for sponsors, ethics boards, or ministries.
🟩 Outcome: Comprehensive support from design through to dissemination.
