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

1. Requirement Understanding & Scope Finalization

2. Regulatory Strategy & Study Design Alignment

3. Clinical Document Preparation / Review

4. Internal Quality & Scientific Review

5. Client Review & Finalization

6. 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.