TrialTrust – Global Clinical Trial Document Writing & Review Services for Haiti
Regulatory-Compliant | Authority-Ready | Globally Trusted
Clinical Trial Documentation Support for Haiti & International Submissions
TrialTrust, the scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing, Review, and Regulatory Support Services for Haiti-based pharmaceutical, nutraceutical, and healthcare organizations, as well as entities conducting or submitting clinical programs in Haiti and global markets.
We support local submissions to the Haitian Ministry of Public Health and Population (MSPP) and export-oriented clinical programs, ensuring documentation aligned with national requirements and harmonized with international clinical research guidelines.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects for clients across Caribbean, LATAM, North America, Europe, Asia, Middle East, and Africa.
Who We Are
TrialTrust is a specialized clinical and regulatory documentation partner supporting:
Haitian pharmaceutical manufacturers and importers
Nutraceutical & dietary supplement companies
Herbal, botanical & traditional medicine developers
NGOs, research institutions & CROs
We specialize in the preparation, independent review, and post-submission query handling of:
Clinical Trial Protocols
Clinical Study Reports (CSR)
All documentation is supported by complete backup data, strong scientific justification, and authority-aligned formats, ensuring inspection-ready and regulator-acceptable submissions.
What We Do
We provide complete lifecycle support for Clinical Trial documentation — from protocol development and ethics approval to final report submission and regulatory authority query closure.
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 & MSPP-ready formats
Alignment with ICH-GCP and WHO clinical research standards
📊 Clinical Study Report (CSR) Writing
Full ICH E3-compliant Clinical Study Reports
Clinical data interpretation & conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator, site & subject data integration
Suitable for MSPP and international submissions
📁 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 review of CT documents
Gap assessment against ICH-GCP, WHO, PAHO, and Haitian regulatory expectations
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
MSPP / Ethics Committee query responses
Scientific rebuttals & regulatory clarifications
Deficiency letter responses
Follow-up support until regulatory closure
Industries We Serve
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
NGO- and donor-funded Clinical Programs
Global Regulatory Alignment
Our Clinical Trial documentation is prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO & PAHO Guidelines
USFDA
EMA
Caribbean & LATAM MOH requirements
Country-specific Ethics Committee formats
Why Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Dedicated Clinical & Regulatory Experts
✅ Pharma & Nutraceutical Specialization
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Strong Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported globally
Clients across Caribbean, LATAM, North America, Europe, Asia, Middle East & Africa
Experience in new products, line extensions & lifecycle management
Support for local registrations and international submissions
Our Working Approach
Requirement Understanding & Scope Finalization
Regulatory Strategy & Study Design Alignment
Clinical Document Preparation / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All projects are handled under strict confidentiality agreements, supported by robust quality control systems, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.