TrialTrust – Global Clinical Trial Document Writing & Review Services for the United States
Regulatory-Compliant | Authority-Ready | Globally Trusted
Clinical Trial Documentation Support for the United States & Global 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 US-based pharmaceutical, nutraceutical, and healthcare companies, as well as organizations pursuing regional and international market approvals.
We support local submissions to the US Food and Drug Administration (FDA) and export-oriented clinical programs, ensuring documentation aligned with US regulations and harmonized with international clinical research standards.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects for clients across North America, LATAM, Europe, Asia, Middle East, and Africa.
Who We Are
TrialTrust is a specialized clinical and regulatory documentation partner supporting:
US pharmaceutical manufacturers and importers
Nutraceutical & dietary supplement companies
Herbal, botanical & functional food product developers
CROs and research institutions
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 FDA-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 IRB submission to final report submission and FDA 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
IRB & FDA-ready formats
Alignment with ICH-GCP and US regulatory expectations
📊 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 FDA, EMA, 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, FDA, WHO, and EMA requirements
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
FDA / IRB 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
FDA Guidelines
WHO & PAHO Guidelines
EMA
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 US, LATAM, 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.