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Evaluation Services: Clinical Trials and Diagnostic Device Evaluations in South Africa

End-to-end study management for diagnostic manufacturers, pharmaceutical companies, research organisations and government agencies. Modular services: commission a full managed study or specific components.

65+ peer-reviewed publications 24 years of research 3 SANAS-accredited labs 9 provinces covered
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Epicentre Research NPC (est. 2001, reg. 2007/003117/08, ROR: 01x2k2x19) provides complete support for diagnostic and point-of-care evaluations. Our infrastructure combines three walk-in laboratories, GCP- and GCLP-certified processes, a national field operations network, and a publication record that includes The Lancet HIV, JAMA Network Open, Nature and PLOS Medicine.

Whether you need a full clinical trial managed from protocol to publication, a standalone device evaluation for WHO prequalification, or a specific component such as ethics submission or participant recruitment, the services below are available individually or as an integrated package.

Who This Is For

Diagnostic Manufacturers

Rapid tests, PCR, point-of-care

Clinical evaluations of rapid diagnostic devices, molecular assays and point-of-care technologies. Protocol design, reference standard testing, sensitivity/specificity analysis, regulatory-ready reporting for WHO prequalification, CE marking and SAHPRA registration.

Pharmaceutical Companies

Phase II – IV, post-market

Clinical trial infrastructure across three urban labs and rural field sites. Participant recruitment through walk-in lab channels and community networks. GCP-certified processes with full ethics and SAHPRA oversight.

Research Organisations

Universities, NGOs, government

Epidemiological surveillance, population-based cohort studies, implementation research. 24 years of collaboration with CAPRISA, NICD, UKZN, SAMRC, CDC/PEPFAR, WHO and FIND.

Service Catalogue

1

Ethics and Regulatory Submissions

Full ethics committee submission and management for South African institutional review boards. SAHPRA (South African Health Products Regulatory Authority) applications where required.

  • Draft and submit complete study protocols to relevant ethics committees
  • Track and manage all documentation until approval is obtained
  • Maintain continuous compliance reporting during the study
  • Manage protocol amendments and annual renewals
  • SAHPRA registration for device evaluations and clinical trials where applicable
2

Study Design and Protocol Development

Fit-for-purpose study protocols, participant information sheets, consent forms and data collection tools aligned with WHO and GCP guidelines.

  • Protocol design with clear primary and secondary endpoints
  • Sample size calculations and statistical analysis plans
  • Participant information sheets in English, isiZulu, isiXhosa and Afrikaans
  • Informed consent documentation meeting SAHPRA and international standards
  • Version-controlled documentation ensuring traceability and reproducibility
3

Standard Operating Procedures

Development or adaptation of SOPs to align with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) guidelines.

  • Laboratory SOPs for sample collection, processing, storage and transport
  • Field operations SOPs for community-based recruitment and testing
  • Data management SOPs covering entry, cleaning, quality assurance and security
  • Safety reporting and adverse event management procedures
  • Chain of custody and specimen tracking protocols
4

Participant Recruitment

Access to Epicentre's walk-in laboratory network and community field operations for direct participant recruitment. Proven enrolment strategies across urban and rural settings.

  • Three walk-in labs (Hillcrest, Observatory, Parktown North) as recruitment sites
  • Community-based recruitment through field teams across nine provinces
  • Electronic enrolment systems including QR-coded advertising for direct connection to testing
  • Targeted recruitment for specific demographics, risk profiles and geographic regions
  • Experience recruiting for HIV, STI, COVID-19, TB and chronic disease studies
5

Sample Collection and Laboratory Testing

SANAS-accredited laboratory infrastructure for blood, swab, urine and stool sample collection. Registered nurses at all sites. Cold chain management for specimen transport.

  • Blood draw, self-collected swab, urine and stool sample collection
  • PCR molecular testing (STI panels, HPV, respiratory, gut microbiome)
  • Immunoassay and serology testing (HIV, hepatitis, syphilis)
  • Reference standard testing for device evaluation comparisons
  • Biobanking and long-term specimen storage where required
  • Cold chain logistics for multi-site and rural collections
6

Diagnostic Device Evaluation

Formal clinical evaluations of rapid diagnostic tests, molecular assays and point-of-care devices. Designed to meet the requirements of WHO prequalification, CE marking, SAHPRA registration and FDA submission.

  • Prospective clinical performance studies (sensitivity, specificity, PPV, NPV)
  • Head-to-head comparisons against established reference standards
  • Usability and workflow assessments in clinical and field settings
  • Lot-to-lot consistency testing
  • Stability and operational performance under South African field conditions
  • Regulatory-ready clinical evaluation reports
7

Data Management and Statistical Analysis

End-to-end data management from collection through to publication-ready analysis. All systems designed for regulatory audit readiness.

  • Electronic data capture system design and deployment
  • Real-time data quality monitoring and query resolution
  • Statistical analysis per protocol-defined analysis plan
  • Sensitivity/specificity calculations with confidence intervals
  • Manuscript-ready tables, figures and statistical reporting
  • Data archiving and audit trail maintenance
8

Reporting and Publication Support

From interim progress reports through to peer-reviewed publication. 65+ papers published in journals including The Lancet HIV, JAMA Network Open, Nature and PLOS Medicine.

  • Interim and final study reports
  • Clinical evaluation reports for regulatory submission
  • Manuscript preparation, statistical review and journal submission support
  • Conference poster and presentation development
  • Plain-language summaries for funders and stakeholders

Track Record

HIPSS

The Lancet HIV

HIV Incidence Provincial Surveillance System. One of the largest population-based HIV studies in South Africa. Partnership with CAPRISA and UKZN, funded by CDC/PEPFAR. Shaped SA's National Strategic Plan.

COVID-19 Antibody Survey

JAMA Network Open

National seroprevalence study measuring COVID-19 antibody levels across South Africa. 13,700 participants tested. Directly informed the government's vaccination strategy.

DREAMS

CDC/PEPFAR

Determined Resilient Empowered AIDS-free Mentored and Safe. Multi-year PEPFAR-funded initiative targeting adolescent girls and young women in high-burden districts.

Research Partners

CAPRISA NICD CDC / PEPFAR WHO FIND UKZN SAMRC

Modular pricing. Every service above is available individually. Commission a full end-to-end managed study, or engage Epicentre for a specific component: ethics submission only, recruitment only, laboratory testing only, data analysis only, or any combination. Request a quote with your study objectives and we will propose a scope and timeline.

Frequently Asked Questions

What clinical trial services does Epicentre offer?
End-to-end study management: protocol design, ethics and SAHPRA submissions, SOP development, participant recruitment across three labs and nine provinces, sample collection and laboratory testing, data management, statistical analysis and publication support. GCP and GCLP certified. 65+ peer-reviewed publications.
Can Epicentre evaluate diagnostic devices?
Yes. Formal clinical evaluations of rapid diagnostic tests, PCR technologies and point-of-care devices. Protocol design, ethics approval, sample collection, reference standard testing, sensitivity/specificity analysis and regulatory-ready reporting for WHO prequalification, CE marking or SAHPRA registration.
What is Epicentre's publication record?
65+ peer-reviewed publications in The Lancet HIV, JAMA Network Open, Nature and PLOS Medicine. Key studies include HIPSS (HIV surveillance), COVID-19 National Antibody Survey (13,700 tested), and DREAMS (PEPFAR). Listed on Nature Index and the Research Organization Registry (ROR ID: 01x2k2x19).
Does Epicentre handle ethics and SAHPRA submissions?
Yes. Full ethics committee submission and management, SAHPRA applications, continuous compliance reporting and amendment management throughout the study lifecycle.
Where does Epicentre operate?
Three laboratories: Hillcrest (Durban, KZN), Observatory (Cape Town, WC), Parktown North (Johannesburg, GP). Field operations across all nine South African provinces. Walk-in lab infrastructure provides direct participant recruitment channels for urban populations.
How do I request a quote?
Email [email protected] or call +27 72 843 7564. Include your study objectives, target population, estimated sample size and desired timeline. Services are modular: full study or individual components.

Ready to Discuss Your Study?

24 years. 65+ publications. Three labs. Nine provinces. GCP/GCLP certified.

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Medical Director: Dr. Samantha Naidoo
MB ChB, FCP (SA) · Epicentre Research NPC · Founded 2001 by Cherie Cawood

Epicentre Research NPC · Reg. 2007/003117/08 · Practice #1117394 · Nature Index · ROR: 01x2k2x19