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TrialTrust Global
Clinical Trial Document Writing & Review Services – Czech Republic
SÚKL-Aligned | Ethics Committee–Ready | EU & Globally Trusted
Trusted Clinical Trial Documentation Partner for the Czech Republic
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 Czech Republic.
The Czech Republic is a central European clinical research hub, selected for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by SÚKL (State Institute for Drug Control) 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 Czech, 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 the Czech Republic
We work with:
Czech & EU pharmaceutical companies
Biotechnology & biosimilar developers
CROs conducting trials in the Czech Republic
Generic & branded product manufacturers
Nutraceutical & dietary supplement companies
Sponsors conducting Czech-only or multi-country EU clinical trials
Whether your study is Czech-only or part of a multi-country EU MRCT, we ensure full SÚKL and Ethics Committee compliance.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Czech 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
SÚKL & Ethics Committee–aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports suitable for Czech Republic, 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 SÚKL, 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:
SÚKL 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:
SÚKL & Ethics Committee query responses
Scientific rebuttals & regulatory clarifications
Deficiency response support
Ongoing authority follow-up until approval
Industries We Support in the Czech Republic
Innovative & Generic Pharmaceuticals
Biotechnology & Biosimilars
Oncology, CNS, Cardiovascular & Vaccine Products
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Export-driven Czech & EU clinical programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
SÚKL (Czech Republic)
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 Czech Republic-Focused Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting Czech & EU Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ Authority-Aligned Documentation for SÚKL & 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, Czech-only, and global lifecycle management
Support for SÚKL approvals and international submissions
Our Working Approach
Requirement Understanding & Czech / EU / Global Scope Finalization
SÚKL & Ethics Committee Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All Czech-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 – Czech Republic Clinical Trial Support
Looking for SÚKL-aligned, Czech/EU-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in the Czech Republic?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.