TrialTrust Global
Clinical Trial Document Writing & Review Services – United Kingdom
MHRA-Aligned | REC-Ready | Globally Trusted
Trusted Clinical Trial Documentation Partner for the United Kingdom
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 conducting clinical trials in the UK.
The UK is a well-established clinical research hub, chosen for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by the MHRA (Medicines and Healthcare products Regulatory Agency) and local Research Ethics Committees (RECs). TrialTrust supports sponsors and CROs with scientifically robust, authority-ready documentation, aligned with UK, EU (where applicable), and global standards.
Since 2008, TrialTrust has delivered 330+ clinical trial documentation projects for clients across Europe, Asia, Middle East, Africa, and LATAM.
Who We Serve in the UK
We work with:
UK & global pharmaceutical companies
Biotechnology & biosimilar developers
CROs conducting trials in the UK
Generic & branded product manufacturers
Nutraceutical & dietary supplement companies
Sponsors conducting UK-only or multi-country clinical trials
Whether your study is UK-only or part of a global MRCT program, we ensure full MHRA and REC compliance.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with UK 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
MHRA & REC–aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports suitable for UK, EU, and global submissions:
End-to-end CSR writing & medical interpretation
Safety & efficacy evaluation
Tables, Listings & Figures (TLFs)
Investigator & site data integration
Clear regulatory-ready clinical conclusions
📁 Backup & Supporting Documentation
Complete supporting documentation required for MHRA, REC, and global regulatory submissions:
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:
MHRA requirements
UK RECs
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
EMA & WHO guidelines (for multi-country submissions)
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
Complete regulatory follow-up support until closure:
MHRA & REC query responses
Scientific rebuttals & regulatory justifications
Deficiency response support
Ongoing authority follow-up until approval
Industries We Support in the UK
Innovative & Generic Pharmaceuticals
Biotechnology & Biosimilars
Oncology, CNS, Cardiovascular & Vaccine Products
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Export-driven UK & Global clinical programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
MHRA (UK)
Research Ethics Committees (RECs)
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
EMA & WHO Guidelines
USFDA (for global programs)
Why UK-Focused Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting UK & Global Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ MHRA & REC-Aligned Documentation
✅ Reliable Post-Submission & Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported worldwide
Clients across Europe, Asia, Middle East, Africa & LATAM
Experience in MRCTs, UK-only, and global lifecycle management
Support for MHRA approvals and global submissions
Our Working Approach
Requirement Understanding & UK / Global Scope Finalization
MHRA & UK Ethics Committee Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All UK-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 UK/global acceptance.
Get in Touch – UK Clinical Trial Support
Looking for MHRA-aligned, UK-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in the United Kingdom?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.