TrialTrust Global
Clinical Trial Document Writing & Review Services – Poland
URPL-Aligned | Bioethics Committee–Ready | EU & Globally Trusted
Trusted Clinical Trial Documentation Partner for Poland
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 or supporting clinical trials in Poland.
Poland is one of Europe’s fastest-growing clinical research hubs, widely selected for Phase I–IV, bioequivalence, oncology, cardiology, CNS, vaccines, and biosimilar studies, regulated by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) and Regional Bioethics Committees. TrialTrust supports sponsors and CROs with scientifically robust, EU-compliant, authority-ready documentation.
Since 2008, TrialTrust has delivered 330+ clinical trial documentation projects for clients across Europe, Asia, Middle East, Africa, and LATAM.
Who We Serve in Poland
We work with:
EU & global pharmaceutical companies
Biotechnology & biosimilar developers
CROs conducting trials in Poland
Generic & branded product manufacturers
Nutraceutical & dietary supplement companies
Sponsors operating under EU Clinical Trials Regulation (EU 536/2014)
Whether your study is Poland-only or part of a multi-country EU / MRCT program, we ensure full URPL, Bioethics Committee, and EU CTR compliance.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Polish 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
URPL & Bioethics Committee–aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports suitable for Poland, 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 URPL, Bioethics Committees, and 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:
URPL requirements
EU Clinical Trials Regulation (EU 536/2014)
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:
URPL & Bioethics Committee query responses
CTIS clarification & deficiency responses
Scientific rebuttals & regulatory justifications
Ongoing authority follow-up support
Industries We Support in Poland
Innovative & Generic Pharmaceuticals
Biotechnology & Biosimilars
Oncology, CNS, Cardiovascular & Vaccine Products
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Export-driven EU clinical programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
URPL (Poland)
Regional Bioethics Committees
EU Clinical Trials Regulation (EU 536/2014)
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
EMA
WHO Guidelines
USFDA (for global programs)
Why Poland-Focused Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting Central & Eastern Europe Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ EU CTR & URPL-Aligned Documentation
✅ 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 CTR, MRCTs & lifecycle management
Support for Polish approvals and global submissions
Our Working Approach
Requirement Understanding & Poland / EU Scope Finalization
URPL & EU Regulatory Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All Poland-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-wide acceptance.
Get in Touch – Poland Clinical Trial Support
Looking for URPL-aligned, EU-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in Poland?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs