TrialTrust – Global Clinical Trial Document Writing & Review Services
For Pharmaceutical & Nutraceutical Companies in Zambia
Regulatory-Compliant | Authority-Ready | Globally Trusted
Who We Are
TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., delivers end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical and nutraceutical products, supporting organizations in Zambia for local regulatory approvals and international market submissions.
Since 2008, TrialTrust has 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 Zambia.
Our Core Clinical Trial Services
🧪 Clinical Trial Protocol Writing
Protocols (Phase I–IV, BA/BE, Pilot & Pivotal studies)
Pharma & nutraceutical protocols
Study design, objectives, endpoints & statistical rationale
Inclusion / exclusion criteria & risk–benefit assessment
Ethics Committee–ready & regulator-aligned formats suitable for Zambia and importing markets
📊 Clinical Study Report (CSR) Writing
ICH E3–compliant CSRs
Clinical 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)
CRF review support
Statistical Analysis Plan (SAP)
Literature reviews & clinical justification documents
🔄 Document Review & Gap Assessment
Independent technical & regulatory reviews
Gap assessment vs ICH-GCP, WHO, ZAMRA, US FDA & EMA expectations
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
ZAMRA / Ethics Committee / FDA / EMA responses
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up until closure
Industries We Serve in Zambia
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
Aligned with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
ZAMRA (Zambia)
US FDA | EMA | GCC
African & LATAM MOH requirements
Country- & ethics committee–specific formats (Zambia & importing markets)
Why Zambia-Based Clients Choose TrialTrust
✅ 330+ 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
Our Working Approach
Requirement understanding & scope finalization
Regulatory strategy & study design alignment
Clinical document preparation / independent review
Internal quality & scientific review
Client review & finalization
Post-submission authority & ethics committee support
Confidentiality & Quality Commitment
All projects operate under strict confidentiality, robust quality systems, version control, and data integrity practices—ensuring regulatory confidence and global acceptance.