TrialTrust – Clinical Trial Document Writing & Review Services (Bangladesh)
egulatory-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 intended for Bangladesh and international markets.
We specialize in preparation, independent review, and post-submission query handling of Clinical Trial Protocols and Clinical Study Reports (CSR), supported by complete backup documentation, scientific justifications, and regulatory-aligned content suitable for DGDA Bangladesh, Ethics Committees, and global authorities.
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 through final report submission and authority query closure—tailored for sponsors, CROs, and manufacturers operating in or submitting to Bangladesh.
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 & DGDA-ready formats
📊 Clinical Study Report (CSR) Writing
Full ICH E3-compliant Clinical Study Reports
Clinical data interpretation & 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 and Bangladesh DGDA expectations
Scientific consistency, data integrity & traceability checks
🛂 Post-Submission Query Handling
DGDA / Ethics Committee query responses
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support till closure
Industries We Serve in Bangladesh
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
Export-oriented & locally conducted Clinical Programs
Global & Bangladesh 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
Bangladesh DGDA & local Ethics Committee formats
Why Choose TrialTrust for Bangladesh?
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Dedicated Clinical & Regulatory Experts
✅ Strong Pharma & Nutraceutical specialization
✅ DGDA-acceptable & inspection-ready documentation
✅ Robust post-submission and authority-query 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 Bangladesh registrations and global submissions
Our Working Approach
Requirement understanding & scope finalization
Regulatory strategy & study design alignment
Clinical document preparation / independent review
Internal quality & scientific review
Client review & finalization
Post-submission authority & Ethics Committee query handling
Confidentiality & Quality Commitment
All projects are executed under strict confidentiality agreements with robust quality control, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.