TrialTrust Global
Clinical Trial Document Writing & Review Services – Vadodara
CDSCO-Compliant | Ethics Committee–Ready | Globally Trusted
Trusted Clinical Trial Documentation Partner for Vadodara
TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical, API, CRO, and nutraceutical companies in Vadodara (Baroda) and Central Gujarat.
Vadodara is a long-established hub for API manufacturing, formulations, CRO operations, and regulated-market exports, and TrialTrust supports companies seeking Indian regulatory approvals and international market access across Asia, Middle East, Africa, Europe, and LATAM.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects, enabling sponsors to achieve regulatory acceptance, inspection readiness, and timely approvals.
Who We Serve in Vadodara & Central Gujarat
We work with:
Pharmaceutical formulation manufacturers
API manufacturers & intermediates producers
Clinical Research Organizations (CROs)
Nutraceutical & dietary supplement manufacturers
Herbal & botanical product companies
Generic & branded pharma organizations
Export-oriented manufacturers targeting regulated markets
Whether your clinical trial is India-based, multi-center, or global, we ensure documentation meets CDSCO, Ethics Committee, and international regulatory expectations.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Indian and international standards:
Phase I–IV Clinical Trial Protocols
BA/BE, Pilot & Pivotal study protocols
Pharma, API & Nutraceutical product protocols
Study design, objectives, endpoints & statistical rationale
Inclusion/exclusion criteria & risk–benefit assessment
Ethics Committee & CDSCO-aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports for Indian and global submissions:
End-to-end CSR writing & medical interpretation
Safety & efficacy evaluation
Tables, Listings & Figures (TLFs)
Investigator & site data integration
Clear clinical conclusions for regulatory submission
📁 Backup & Supporting Documentation
Complete support documentation required for approvals and exports:
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 scientific and regulatory review services:
Gap assessment against:
ICH-GCP (E6)
New Drugs & Clinical Trials Rules (NDCTR), India
CDSCO / SEC expectations
WHO, USFDA & EMA guidelines
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
End-to-end regulatory follow-up support until closure:
CDSCO / SEC / Ethics Committee query responses
Scientific rebuttals & clarification documents
Deficiency letter responses
Ongoing regulatory follow-up support
Industries We Support in Vadodara
Pharmaceutical Finished Dosage Forms
Active Pharmaceutical Ingredients (APIs)
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
CRO-driven clinical development programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
CDSCO (India)
NDCTR, 2019
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
USFDA
EMA
ASEAN, GCC, African & LATAM MOH requirements
Ethics Committee-specific formats
Why Vadodara Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered
✅ Strong Experience Supporting Gujarat’s API & Pharma Clusters
✅ Expertise in Pharma, API, CRO & Nutraceutical Products
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Reliable Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported globally
Clients across India, Asia, Middle East, Africa, Europe & LATAM
Experience in APIs, formulations, CRO-led trials & lifecycle management
Support for Indian registrations and global exports
Our Working Approach
Requirement Understanding & Scope Finalization
CDSCO & Global Regulatory Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All Vadodara projects are managed under strict confidentiality agreements, supported by:
Robust quality control systems
Version control & audit readiness
Scientific accuracy & data integrity assurance
Ensuring regulatory confidence and global acceptance.
Get in Touch – Vadodara Clinical Trial Support
Looking for CDSCO-ready, globally accepted Clinical Trial documentation for your pharma, API, CRO, or nutraceutical product in Vadodara (Baroda)?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.