TrialTrust Global

Clinical Trial Document Writing & Review Services – Sweden

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

Trusted Clinical Trial Documentation Partner for Sweden

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 Sweden.

Sweden is a leading Nordic clinical research hub, selected for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by the Swedish Medical Products Agency (MPA / Läkemedelsverket) and regional Ethics Committees. TrialTrust supports sponsors and CROs with scientifically robust, authority-ready documentation, aligned with Swedish, 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 Sweden

We work with:

• EU & global pharmaceutical companies

• Biotechnology & biosimilar developers

• CROs conducting trials in Sweden

• Generic & branded product manufacturers

• Nutraceutical & dietary supplement companies

• Sponsors conducting Nordic or EU clinical trials

Whether your study is Sweden-only or part of a multi-country Nordic/EU MRCT, we ensure full MPA, Ethics Committee, and ICH-GCP compliance.

Our Clinical Trial Documentation Services

🧪 Clinical Trial Protocol Writing

Regulatory-ready Clinical Trial Protocols aligned with Swedish 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

• MPA & Ethics Committee–aligned formats

📊 Clinical Study Report (CSR) Writing

Comprehensive ICH E3-compliant Clinical Study Reports suitable for Sweden, 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 MPA, 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:

  • MPA 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:

• MPA & Ethics Committee query responses

• CTIS clarification & deficiency responses

• Scientific rebuttals & regulatory justifications

• Ongoing authority follow-up support

Industries We Support in Sweden

• 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:

• MPA / Läkemedelsverket (Sweden)

• Regional Ethics Committees

• 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 Sweden-Focused Companies Choose TrialTrust

✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting Nordic & EU Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ EU CTR & MPA-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 Swedish approvals and global submissions

Our Working Approach

1. Requirement Understanding & Sweden / Nordic / EU Scope Finalization

2. MPA & EU/Nordic Regulatory 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 Sweden-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 – Sweden Clinical Trial Support

Looking for MPA-aligned, EU/Nordic-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in Sweden?

Partner with TrialTrust — where clinical science meets regulatory excellence.

📩 Contact us today to discuss your Clinical Trial documentation needs