TrialTrust Global

Clinical Trial Document Writing & Review Services – Austria

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

Trusted Clinical Trial Documentation Partner for Austria

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 Austria.

Austria is a central European clinical research hub, selected for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by AGES (Austrian Agency for Health and Food Safety) and local Ethics Committees, in line with the EU Clinical Trials Regulation (EU CTR 536/2014). TrialTrust supports sponsors and CROs with scientifically robust, authority-ready documentation, aligned with Austrian, 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 Austria

We work with:

• Austrian & EU pharmaceutical companies

• Biotechnology & biosimilar developers

• CROs conducting trials in Austria

• Generic & branded product manufacturers

• Nutraceutical & dietary supplement companies

• Sponsors conducting Austria-only or multi-country EU clinical trials

Whether your study is Austria-only or part of a multi-country EU MRCT, we ensure full AGES and Ethics Committee compliance.

Our Clinical Trial Documentation Services

🧪 Clinical Trial Protocol Writing

Regulatory-ready Clinical Trial Protocols aligned with Austrian 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

• AGES & Ethics Committee–aligned formats

📊 Clinical Study Report (CSR) Writing

Comprehensive ICH E3-compliant Clinical Study Reports suitable for Austria, 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 AGES, 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:

  • AGES requirements

  • Local Ethics Committees

  • 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:

• AGES & Ethics Committee query responses

• Scientific rebuttals & regulatory clarifications

• Deficiency response support

• Ongoing authority follow-up until approval

Industries We Support in Austria

• Innovative & Generic Pharmaceuticals

• Biotechnology & Biosimilars

• Oncology, CNS, Cardiovascular & Vaccine Products

• Nutraceuticals & Dietary Supplements

• Herbal & Botanical Products

• Export-driven Austrian & EU clinical programs

Regulatory Alignment & Compliance

All clinical trial documents are prepared in alignment with:

• AGES (Austria)

• Local 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 Austria-Focused Companies Choose TrialTrust

✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting Austrian & EU Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ Authority-Aligned Documentation for AGES & Ethics Committees
✅ 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 MRCTs, Austria-only, and global lifecycle management

• Support for AGES approvals and international submissions

Our Working Approach

1. Requirement Understanding & Austria / EU / Global Scope Finalization

2. AGES & Ethics Committee 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 Austria-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/global acceptance.

Get in Touch – Austria Clinical Trial Support

Looking for AGES-aligned, Austria/EU-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in Austria?

Partner with TrialTrust — where clinical science meets regulatory excellence.

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