TrialTrust Global

Clinical Trial Document Writing & Review Services – South Africa

SAHPRA-Aligned | Ethics Committee–Ready | Globally Trusted

Trusted Clinical Trial Documentation Partner for South Africa

TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical, biotechnology, and nutraceutical companies operating in South Africa or targeting the South African market.

South Africa is a leading destination for early- and late-phase clinical trials, including HIV, oncology, vaccines, biosimilars, generics, and nutraceutical studies, governed by the South African Health Products Regulatory Authority (SAHPRA). TrialTrust supports sponsors and CROs with scientifically sound, authority-ready clinical documentation that meets local and global regulatory expectations.

Since 2008, TrialTrust has delivered 330+ clinical trial documentation projects for clients across Africa, Asia, Middle East, Europe, and LATAM.

Who We Serve in South Africa

We work with:

• Pharmaceutical & biotechnology companies

• Generic, innovative & biosimilar manufacturers

• CROs conducting trials in South Africa

• Vaccine, oncology & infectious disease sponsors

• Nutraceutical & dietary supplement companies

• Export-oriented companies targeting Africa and global markets

Whether your trial is South Africa-based, Africa-focused, or part of a multi-regional clinical trial (MRCT), we ensure full SAHPRA and Ethics Committee compliance.

Our Clinical Trial Documentation Services

🧪 Clinical Trial Protocol Writing

Regulatory-ready Clinical Trial Protocols aligned with SAHPRA and international guidelines:

• Phase I–IV Clinical Trial Protocols

• BA/BE, Pilot & Pivotal study protocols

• Pharma, Biotech & Nutraceutical product protocols

• Study design, objectives, endpoints & statistical rationale

• Inclusion/exclusion criteria & risk–benefit assessment

• SAHPRA & Ethics Committee-aligned formats

📊 Clinical Study Report (CSR) Writing

Comprehensive ICH E3-compliant Clinical Study Reports suitable for South African and global submissions:

• Full CSR writing & medical interpretation

• Safety & efficacy evaluation

• Tables, Listings & Figures (TLFs)

• Investigator & site data integration

• Clear regulatory-ready clinical conclusions

📁 Backup & Supporting Documentation

Complete supporting documentation required for SAHPRA, NHREC, and Ethics Committees:

• Investigator’s Brochure (IB)

• Informed Consent Forms (ICF)

• Case Report Form (CRF) review support

• Statistical Analysis Plan (SAP)

• Literature review & clinical justification documents

🔄 Document Review & Gap Assessment

Independent scientific and regulatory review services:

• Gap assessment against:

  • SAHPRA clinical trial requirements

  • ICH-GCP (E6)

  • ICH E3 – Clinical Study Reports

  • WHO, USFDA & EMA guidelines

• Scientific consistency & data integrity checks

• Africa-specific regulatory readiness assessment

🛂 Post-Submission Query Handling

Complete regulatory follow-up support until closure:

• SAHPRA & Ethics Committee query responses

• Scientific rebuttals & clarification documents

• Deficiency letter responses

• Ongoing regulatory follow-up support

Industries We Support in South Africa

• Innovative & Generic Pharmaceuticals

• Biotechnology & Biosimilars

• Vaccines & Infectious Disease Products

• Nutraceuticals & Dietary Supplements

• Herbal & Botanical Products

• Functional Foods & Medical Nutrition

• Export-driven African clinical programs

Regulatory Alignment & Compliance

All clinical trial documents are prepared in alignment with:

• SAHPRA (South Africa)

• NHREC & Institutional Ethics Committees

• ICH-GCP (E6)

• ICH E3 – Clinical Study Reports

• WHO Guidelines

• USFDA

• EMA

• African & LATAM MOH requirements

Why South Africa-Focused Companies Choose TrialTrust

✅ 330+ Clinical Trial Documents Delivered Globally
✅ Experience Supporting African Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ SAHPRA-Aligned & Globally Acceptable Documentation
✅ Strong Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution

Our Experience Footprint

• 330+ products supported worldwide

• Clients across Africa, Asia, Middle East, Europe & LATAM

• Experience in MRCTs, Africa-focused studies & lifecycle management

• Support for South African registrations and global submissions

Our Working Approach

1. Requirement Understanding & SAHPRA Scope Finalization

2. South Africa & Global Regulatory Strategy Alignment

3. Clinical Document Writing / Review

4. Internal Quality & Scientific Review

5. Client Review & Finalization

6. Post-Submission Authority Query Handling

Confidentiality & Quality Commitment

All South Africa-related projects are handled under strict confidentiality agreements, supported by:

• Robust quality control systems

• Version control & audit readiness

• Scientific accuracy & data integrity assurance

Ensuring regulatory confidence and global acceptance.

Get in Touch – South Africa Clinical Trial Support

Looking for SAHPRA-aligned, globally accepted Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in South Africa?

Partner with TrialTrust — where clinical science meets regulatory excellence.

📩 Contact us today to discuss your Clinical Trial documentation needs.