TrialTrust Global

Clinical Trial Document Writing & Review Services – Belgium

FAMHP-Aligned | Ethics Committee–Ready | EU & Globally Trusted

Trusted Clinical Trial Documentation Partner for Belgium

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 Belgium.

Belgium is a key clinical research hub in Europe, selected for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by FAMHP (Federal Agency for Medicines and Health Products) and local Ethics Committees, in line with the EU Clinical Trials Regulation (EU CTR 536/2014). TrialTrust supports sponsors and CROs with scientifically robust, authority-ready documentation, aligned with Belgian, EU, 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 Belgium

We work with:

• Belgian & EU pharmaceutical companies

• Biotechnology & biosimilar developers

• CROs conducting trials in Belgium

• Generic & branded product manufacturers

• Nutraceutical & dietary supplement companies

• Sponsors conducting Belgium-only or multi-country EU clinical trials

Whether your study is Belgium-only or part of a multi-country EU MRCT, we ensure full FAMHP and Ethics Committee compliance.

Our Clinical Trial Documentation Services

🧪 Clinical Trial Protocol Writing

Regulatory-ready Clinical Trial Protocols aligned with Belgian and EU 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

• FAMHP & Ethics Committee–aligned formats

📊 Clinical Study Report (CSR) Writing

Comprehensive ICH E3-compliant Clinical Study Reports suitable for Belgium, 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 FAMHP, Ethics Committees, and EU/CTIS 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:

  • FAMHP requirements

  • Local Ethics Committees

  • ICH-GCP (E6)

  • ICH E3 – Clinical Study Reports

  • EMA & WHO guidelines

• Scientific consistency & data integrity checks

🛂 Post-Submission Query Handling

Complete regulatory follow-up support until closure:

• FAMHP & Ethics Committee query responses

• Scientific rebuttals & regulatory clarifications

• Deficiency response support

• Ongoing authority follow-up until approval

Industries We Support in Belgium

• Innovative & Generic Pharmaceuticals

• Biotechnology & Biosimilars

• Oncology, CNS, Cardiovascular & Vaccine Products

• Nutraceuticals & Dietary Supplements

• Herbal & Botanical Products

• Export-driven Belgian & EU clinical programs

Regulatory Alignment & Compliance

All clinical trial documents are prepared in alignment with:

• FAMHP (Belgium)

• Local Ethics Committees

• EU Clinical Trials Regulation (EU 536/2014)

• ICH-GCP (E6)

• ICH E3 – Clinical Study Reports

• EMA & WHO Guidelines

• USFDA (for global programs)

Why Belgium-Focused Companies Choose TrialTrust

✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting Belgian & EU Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ Authority-Aligned Documentation for FAMHP & Ethics Committees
✅ Reliable Post-Submission & CTIS Support
✅ Confidential, Accurate & Timeline-Driven Execution

Our Experience Footprint

• 330+ products supported worldwide

• Clients across Europe, Asia, Middle East, Africa & LATAM

• Experience in EU MRCTs, Belgium-only, and global lifecycle management

• Support for FAMHP approvals and international submissions

Our Working Approach

1. Requirement Understanding & Belgium / EU / Global Scope Finalization

2. FAMHP & Ethics Committee Strategy Alignment

3. Clinical Document Writing / Review

4. Internal Quality & Scientific Review

5. Client Review & Finalization

6. Post-Submission Authority Query Handling

Confidentiality & Quality Commitment

All Belgium-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 EU/global acceptance.

Get in Touch – Belgium Clinical Trial Support

Looking for FAMHP-aligned, Belgium/EU-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in Belgium?

Partner with TrialTrust — where clinical science meets regulatory excellence.

📩 Contact us today to discuss your Clinical Trial documentation needs