TrialTrust Global

Clinical Trial Document Writing & Review Services – Latvia

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

Trusted Clinical Trial Documentation Partner for Latvia

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 Latvia.

Latvia is a growing EU clinical research destination, chosen for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by the Latvian State Agency of Medicines (ZVA) and local 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 Latvia

We work with:

  • EU & global pharmaceutical companies

  • Biotechnology & biosimilar developers

  • CROs conducting trials in Latvia

  • Generic & branded product manufacturers

  • Nutraceutical & dietary supplement companies

  • Sponsors operating under EU Clinical Trials Regulation (EU 536/2014)

Whether your study is Latvia-only or part of a multi-country EU / MRCT program, we ensure full ZVA, Ethics Committee, and EU CTR compliance.

Our Clinical Trial Documentation Services

🧪 Clinical Trial Protocol Writing

Regulatory-ready Clinical Trial Protocols aligned with Latvian 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

  • ZVA & Ethics Committee–aligned formats

📊 Clinical Study Report (CSR) Writing

Comprehensive ICH E3-compliant Clinical Study Reports suitable for Latvia, 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 ZVA, 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:

    • ZVA 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:

  • ZVA & Ethics Committee query responses

  • CTIS clarification & deficiency responses

  • Scientific rebuttals & regulatory justifications

  • Ongoing authority follow-up support

Industries We Support in Latvia

  • 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:

  • ZVA (Latvia)

  • 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 Latvia-Focused Companies Choose TrialTrust

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

Our Working Approach

  1. Requirement Understanding & Latvia / EU Scope Finalization

  2. ZVA & EU 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 Latvia-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 – Latvia Clinical Trial Support

Looking for ZVA-aligned, EU-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in Latvia?

Partner with TrialTrust — where clinical science meets regulatory excellence.

📩 Contact us today to discuss your Clinical Trial documentation needs.