TrialTrust — Global Experience. Local Regulatory Precision
A Brand of Zoesoe Exports Pvt Ltd
“Clinical Trial Documentation. Regulator-Trusted. Globally Accepted.”
Global Clinical Trial Document Writing & Review Services
TrialTrust Global Clinical Trial Document Writing & Review Services
Regulatory-Compliant | Authority-Ready | Globally Trusted
Who We Are
TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical and nutraceutical products across regulated and semi-regulated global markets.
We specialize in the preparation, review, and post-submission query handling of Clinical Trial Protocols and Clinical Study Reports, supported by complete backup data, scientific justifications, and regulatory-aligned documentation.
Since 2008, TrialTrust has successfully supported 330+ clinical trial documentation projects for clients across Asia, Middle East, Africa, Europe, and LATAM.
What We Do
We provide complete lifecycle support for Clinical Trial documentation, from protocol development to final report submission and authority query responses.
Our Core Clinical Trial Services
🧪 Clinical Trial Protocol Writing
Clinical Trial Protocols (Phase I–IV, BA/BE, Pilot & Pivotal studies)
Protocols for Pharma & Nutraceutical products
Study design, objectives, endpoints & statistical rationale
Inclusion/exclusion criteria & risk–benefit assessment
Ethics committee & regulatory-ready formats
📊 Clinical Study Report (CSR) Writing
Full Clinical Study Reports (ICH E3 compliant)
Data interpretation & clinical conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator and site data integration
📁 Backup & Supporting Documentation
Investigator’s Brochure (IB)
Informed Consent Forms (ICF)
Case Report Form (CRF) review support
Statistical Analysis Plan (SAP)
Literature review & clinical justification documents
🔄 Document Review & Gap Assessment
Independent technical & regulatory review of CT documents
Gap assessment against ICH-GCP, WHO, USFDA, EMA & local MOH expectations
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
MOH / FDA / Ethics Committee query responses
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support till 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 documents are prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
USFDA
EMA
ASEAN
GCC
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 Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported globally
Clients across Asia, Middle East, Africa, Europe & LATAM
Experience in new products, line extensions & lifecycle management
Support for local registrations and global 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, with robust quality control, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.
Get in Touch
Looking for reliable, regulatory-ready Clinical Trial documentation support for your Pharma or Nutraceutical product?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.
“Clinical Trial Documentation. Regulator-Trusted. Globally Accepted.”
Excellence in Clinical Trial Research & Compliance.
📌 Frequently Asked Questions (FAQ) – Global Clinical Trial Document Writing & Review Services
1. What services does TrialTrust provide?
TrialTrust provides end-to-end Clinical Trial (CT) document writing and review services for pharmaceutical and nutraceutical products, including Clinical Trial Protocols, Clinical Study Reports (CSRs), backup documentation, and post-submission regulatory query handling.
2. Which types of products do you support?
We support:
Pharmaceutical finished dosage forms
Nutraceuticals & dietary supplements
Herbal & botanical products
Functional foods & medical nutrition
Generic and branded products
Our services are suitable for both local and global regulatory submissions.
3. Do you prepare both Clinical Trial Protocols and Reports?
Yes. We prepare and review:
Clinical Trial Protocols (Phase I–IV, BA/BE, pilot & pivotal studies)
Clinical Study Reports (CSR) in compliance with ICH E3 guidelines
All documents are supported with complete scientific justification and backup data.
4. Are your clinical trial documents regulator-acceptable?
Yes. All documents are prepared in alignment with:
ICH-GCP
WHO guidelines
USFDA, EMA, ASEAN, GCC & local MOH expectations
Country-specific Ethics Committee requirements
Our focus is on authority-ready and inspection-acceptable documentation.
5. Do you offer review of existing clinical trial documents?
Yes. We provide independent technical and regulatory review of existing Clinical Trial Protocols, CSRs, and supporting documents, including gap assessment, deficiency identification, and improvement recommendations.
6. Can TrialTrust support post-submission regulatory queries?
Absolutely. We handle MOH / FDA / Ethics Committee queries related to clinical trial documentation, including:
Scientific clarifications
Deficiency letter responses
Rebuttals and justifications
Follow-up support until query closure
7. Do you work with CROs, sponsors, or manufacturers?
Yes. We work with:
Pharmaceutical manufacturers
Nutraceutical companies
Product sponsors
CROs & research organizations
Export-oriented regulatory teams
We seamlessly integrate with your existing clinical and regulatory setup.
8. In which regions do you provide services?
TrialTrust supports clients across:
Asia
Middle East
Africa
Europe
LATAM
Our documentation is customized as per country-specific regulatory expectations.
9. How much experience does TrialTrust have in clinical trial documentation?
TrialTrust has experience in 330+ clinical trial documentation projects globally, supported by a multidisciplinary team of clinical, regulatory, QA, and scientific experts.
10. Do you support nutraceutical clinical trials?
Yes. We have strong experience in nutraceutical and dietary supplement clinical trial documentation, including efficacy, safety, and functional claim-based studies aligned with global regulatory expectations.
11. How do you ensure confidentiality of clinical data?
We follow strict confidentiality, data security, and document control procedures. All projects are handled under confidentiality agreements, ensuring protection of proprietary and clinical data.
12. Can TrialTrust customize documents as per local authority formats?
Yes. We customize clinical trial documents as per:
Local MOH templates
Ethics Committee formats
Country-specific submission requirements
This ensures smooth review and faster approvals.
13. Do you provide complete backup data with clinical documents?
Yes. All deliverables are supported with complete backup data, references, scientific rationales, and traceability to ensure regulatory confidence and acceptance.
14. How do we initiate a project with TrialTrust?
You can initiate a project by:
Sharing your product details and target country
Defining scope (protocol, report, review, or query handling)
Finalizing timelines and deliverables
Our team will guide you through the process step-by-step.
15. Why should we choose TrialTrust over a CRO?
TrialTrust focuses exclusively on clinical documentation excellence, regulatory alignment, and post-submission support.
We complement CROs by ensuring your clinical documents are scientifically strong, regulator-acceptable, and inspection-ready.