TrialTrust Global
Clinical Trial Document Writing & Review Services – China
NMPA-Aligned | Ethics Committee–Ready | Globally Trusted
Trusted Clinical Trial Documentation Partner for China
TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical, biotechnology, and nutraceutical companies operating in China or targeting the Chinese market.
China is a critical market for innovative drugs, generics, biosimilars, and nutraceutical products, with strict regulatory expectations under the National Medical Products Administration (NMPA). TrialTrust supports companies with scientifically robust, authority-ready clinical documentation accepted both in China and global markets.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects for clients across Asia, Middle East, Africa, Europe, LATAM, and global export markets.
Who We Serve in China
We work with:
Pharmaceutical & biotechnology companies
Generic, innovative & biosimilar manufacturers
Nutraceutical & dietary supplement companies
Herbal, botanical & traditional medicine developers
CROs supporting China-based or multi-regional trials
Export-oriented companies targeting China and overseas markets
Whether your clinical trial is conducted in China, outside China, or as part of a multi-regional clinical trial (MRCT), we ensure documentation meets NMPA and international regulatory expectations.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with China NMPA and global standards:
Phase I–IV Clinical Trial Protocols
BA/BE, Pilot & Pivotal study protocols
Pharma, Biotech & Nutraceutical product protocols
Study design, objectives, endpoints & statistical rationale
Inclusion/exclusion criteria & risk–benefit assessment
Ethics Committee & NMPA-aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports suitable for China and global submissions:
Full CSR writing & medical interpretation
Safety & efficacy evaluation
Tables, Listings & Figures (TLFs)
Investigator & site data integration
Clear clinical conclusions & regulatory narratives
📁 Backup & Supporting Documentation
Complete supporting documentation required for NMPA, Ethics Committees, and global authorities:
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:
NMPA (China) clinical trial requirements
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO, USFDA & EMA guidelines
Scientific consistency & data integrity checks
MRCT and bridging study readiness assessment
🛂 Post-Submission Query Handling
Complete regulatory follow-up support until closure:
NMPA & Ethics Committee query responses
Scientific rebuttals & clarification documents
Deficiency letter responses
Ongoing regulatory follow-up support
Industries We Support in China
Innovative & Generic Pharmaceuticals
Biotechnology & Biosimilars
Nutraceuticals & Dietary Supplements
Herbal, Botanical & Traditional Medicine Products
Functional Foods & Medical Nutrition
Export-driven clinical development programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
NMPA (China)
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
USFDA
EMA
ASEAN, GCC, African & LATAM MOH requirements
Country-specific Ethics Committee formats
Why China-Focused Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Experience Supporting Asian & Multi-Regional Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ NMPA-Aligned & Globally Acceptable Documentation
✅ Strong Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported worldwide
Clients across Asia, Middle East, Africa, Europe & LATAM
Experience in MRCTs, bridging studies & lifecycle management
Support for China registrations and global submissions
Our Working Approach
Requirement Understanding & China Regulatory Scope Finalization
NMPA & Global Regulatory Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All China-related projects are handled 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 – China Clinical Trial Support
Looking for NMPA-aligned, globally accepted Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in China?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.