TrialTrust Global
Clinical Trial Document Writing & Review Services – Denmark
DKMA-Aligned | Ethics Committee–Ready | EU & Globally Trusted
Trusted Clinical Trial Documentation Partner for Denmark
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 Denmark.
Denmark is a key EU clinical research hub, renowned for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by the Danish Medicines Agency (DKMA) and Regional Ethics 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 Denmark
We work with:
EU & global pharmaceutical companies
Biotechnology & biosimilar developers
CROs conducting trials in Denmark
Generic & branded product manufacturers
Nutraceutical & dietary supplement companies
Sponsors conducting trials under EU Clinical Trials Regulation (EU 536/2014)
Whether your study is Denmark-only or part of a multi-country EU / MRCT program, we ensure full DKMA, Ethics Committee, and EU CTR compliance.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Danish 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
DKMA & Ethics Committee–aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports suitable for Denmark, 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 DKMA, Ethics 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:
DKMA 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:
DKMA & Ethics Committee query responses
CTIS clarification & deficiency responses
Scientific rebuttals & regulatory justifications
Ongoing authority follow-up support
Industries We Support in Denmark
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:
DKMA (Denmark)
Regional 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 Denmark-Focused Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting EU Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ EU CTR & DKMA-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 Danish approvals and global submissions
Our Working Approach
Requirement Understanding & Denmark / EU Scope Finalization
DKMA & EU Regulatory Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All Denmark-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 – Denmark Clinical Trial Support
Looking for DKMA-aligned, EU-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in Denmark?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs