TrialTrust – Global Clinical Trial Document Writing & Review Services

For Pharmaceutical & Nutraceutical Companies in Zanzibar

Regulatory-Compliant | Authority-Ready | Globally Trusted

Who We Are

TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical and nutraceutical products, supporting organizations in Zanzibar for local regulatory and ethics submissions as well as international market approvals.

Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects across Asia, Middle East, Africa, Europe, and LATAM, ensuring scientific rigor, regulatory compliance, and authority acceptance.

What We Do

We provide complete lifecycle support for Clinical Trial documentation—from protocol development to final report submission and post-submission authority / ethics committee query resolution—tailored for sponsors, manufacturers, MAHs, CRO-linked programs, and exporters operating in or from Zanzibar.

Our Core Clinical Trial Services

🧪 Clinical Trial Protocol Writing

• Clinical Trial Protocols (Phase I–IV, BA/BE, Pilot & Pivotal studies)

• Protocols for Pharmaceutical & Nutraceutical products

• Study design, objectives, endpoints & statistical rationale

• Inclusion / exclusion criteria & risk–benefit assessment

• Ethics Committee–ready & regulator-aligned formats (Zanzibar & Tanzania-aligned)

📊 Clinical Study Report (CSR) Writing

• ICH E3–compliant Clinical Study Reports

• Clinical data interpretation & conclusions

• Tables, Listings & Figures (TLFs)

• Safety & efficacy evaluation

• Investigator, site & multicenter data integration

📁 Backup & Supporting Documentation

• Investigator’s Brochure (IB)

• Informed Consent Forms (ICF)

• Case Report Form (CRF) review support

• Statistical Analysis Plan (SAP)

• Literature reviews & clinical justification documents

🔄 Document Review & Gap Assessment

• Independent technical & regulatory reviews

• Gap assessment against ICH-GCP, WHO, TMDA (Tanzania), US FDA & EMA expectations

• Scientific consistency, traceability & data integrity checks

🛂 Post-Submission Query Handling

• Ethics Committee / TMDA / MOH query responses

• Scientific rebuttals & clarifications

• Deficiency letter responses

• Regulatory follow-up support until closure

Industries We Serve in Zanzibar

• Pharmaceutical Finished Dosage Forms

• Nutraceuticals & Dietary Supplements

• Herbal & Botanical Products

• Functional Foods & Medical Nutrition

• Generic & Branded Products

• Export-oriented & multi-country clinical programs

Global Regulatory Alignment

Our documentation aligns with:

• ICH-GCP (E6)

• ICH E3 – Clinical Study Reports

• WHO Guidelines

• TMDA (Tanzania)

• US FDA | EMA | GCC

• African & LATAM MOH requirements

• Country- and ethics committee–specific formats (Zanzibar & importing markets)

Why Zanzibar-Based Clients Choose TrialTrust

✅ 330+ Clinical Trial Documents Delivered Globally
✅ Dedicated Clinical, Statistical & Regulatory Experts
✅ Strong Pharma & Nutraceutical specialization
✅ Authority-acceptable & inspection-ready documentation
✅ Proven post-submission query handling
✅ Confidential, accurate & timeline-driven execution