TrialTrust – Global Clinical Trial Document Writing & Review Services for Fiji
Regulatory-Compliant | Authority-Ready | Globally Trusted
Clinical Trial Documentation Support for Fiji & 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 Fiji-based pharmaceutical, nutraceutical, and healthcare companies, as well as organizations conducting or submitting clinical programs within the Pacific region and global markets.
We support local submissions to the Fiji Ministry of Health & Medical Services (MoHMS) and export-oriented clinical programs, ensuring documentation aligned with national ethics and regulatory expectations and harmonized with international guidelines.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects for clients across Asia-Pacific, Europe, Middle East, Africa, and LATAM.
Who We Are
TrialTrust is a specialized clinical and regulatory documentation partner supporting:
Fiji pharmaceutical manufacturers and importers
Nutraceutical & dietary supplement companies
Herbal, traditional & natural health product developers
Export-focused product owners and 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 submission through final report submission and 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 & Fiji MoHMS-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 Fiji MoHMS, regional, and global 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, and local MoHMS expectations
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
Fiji MoHMS / 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
Export-oriented Clinical Programs
Global Regulatory Alignment
Our Clinical Trial documentation is prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
USFDA
EMA
ASEAN & Asia-Pacific regulatory expectations
African & 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 Asia-Pacific, Europe, Middle East, Africa & LATAM
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 executed under strict confidentiality agreements, supported by robust quality control systems, version management, and data integrity practices, ensuring regulatory confidence and global acceptance.
Get in Touch
Looking for reliable, regulatory-ready Clinical Trial documentation support for your pharmaceutical or nutraceutical product in Fiji?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation requirements.