TrialTrust Global
Clinical Trial Document Writing & Review Services – Norway
NoMA-Aligned | Ethics Committee–Ready | EU & Globally Trusted
Trusted Clinical Trial Documentation Partner for Norway
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 Norway.
Norway is a key Nordic clinical research hub, selected for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by the Norwegian Medicines Agency (NoMA) and regional Ethics Committees (REKs). TrialTrust supports sponsors and CROs with scientifically robust, authority-ready documentation, aligned with Norwegian, 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 Norway
We work with:
EU & global pharmaceutical companies
Biotechnology & biosimilar developers
CROs conducting trials in Norway
Generic & branded product manufacturers
Nutraceutical & dietary supplement companies
Sponsors conducting Nordic or EU clinical trials
Whether your study is Norway-only or part of a multi-country Nordic/EU MRCT, we ensure full NoMA, REK, and ICH-GCP compliance.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Norwegian and Nordic 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
NoMA & Ethics Committee–aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports suitable for Norway, 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 NoMA, 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:
NoMA requirements
EU Clinical Trials Regulation (EU 536/2014) for Nordic/EU trials
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:
NoMA & Ethics Committee query responses
CTIS clarification & deficiency responses
Scientific rebuttals & regulatory justifications
Ongoing authority follow-up support
Industries We Support in Norway
Innovative & Generic Pharmaceuticals
Biotechnology & Biosimilars
Oncology, CNS, Cardiovascular & Vaccine Products
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Export-driven Nordic/EU clinical programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
NoMA (Norway)
Regional Ethics Committees (REKs)
EU Clinical Trials Regulation (EU 536/2014) where applicable
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
EMA
WHO Guidelines
USFDA (for global programs)
Why Norway-Focused Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting Nordic & EU Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ NoMA & Nordic Ethics Committee-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 Nordic/EU MRCTs & lifecycle management
Support for Norwegian approvals and global submissions
Our Working Approach
Requirement Understanding & Norway / Nordic / EU Scope Finalization
NoMA & EU/Nordic Regulatory Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All Norway-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 Nordic/EU-wide acceptance.
Get in Touch – Norway Clinical Trial Support
Looking for NoMA-aligned, EU/Nordic-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in Norway?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs