TrialTrust Global
Clinical Trial Document Writing & Review Services – New Zealand
Medsafe-Aligned | HDEC-Ready | Globally Trusted
Trusted Clinical Trial Documentation Partner for New Zealand
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 New Zealand.
New Zealand is a recognized clinical research hub in the Asia-Pacific region, selected for Phase I–IV, bioequivalence, oncology, CNS, cardiovascular, and vaccine studies, regulated by Medsafe and local Health and Disability Ethics Committees (HDECs). TrialTrust supports sponsors and CROs with scientifically robust, authority-ready documentation, aligned with New Zealand 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 New Zealand
We work with:
New Zealand & global pharmaceutical companies
Biotechnology & biosimilar developers
CROs conducting trials in New Zealand
Generic & branded product manufacturers
Nutraceutical & dietary supplement companies
Sponsors conducting New Zealand-only or multi-country regional trials
Whether your study is New Zealand-only or part of an APAC/global MRCT program, we ensure full Medsafe and HDEC compliance.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with New Zealand 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
Medsafe & HDEC–aligned formats
📊 Clinical Study Report (CSR) Writing
Comprehensive ICH E3-compliant Clinical Study Reports suitable for New Zealand 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 Medsafe and HDEC 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:
Medsafe requirements
Health and Disability Ethics Committees (HDECs)
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
EMA, USFDA & WHO guidelines
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
Complete regulatory follow-up support until closure:
Medsafe & HDEC query responses
Scientific rebuttals & regulatory clarifications
Deficiency response support
Ongoing authority follow-up until approval
Industries We Support in New Zealand
Innovative & Generic Pharmaceuticals
Biotechnology & Biosimilars
Oncology, CNS, Cardiovascular & Vaccine Products
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Export-driven New Zealand & global clinical programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
Medsafe (New Zealand)
Health and Disability Ethics Committees (HDECs)
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
EMA, WHO & USFDA guidelines
Why New Zealand-Focused Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Strong Experience Supporting New Zealand & APAC Clinical Trials
✅ Expertise in Pharma, Biotech & Nutraceutical Products
✅ Medsafe & HDEC-Aligned Documentation
✅ Reliable Post-Submission & Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported worldwide
Clients across Europe, Asia, Middle East, Africa & LATAM
Experience in MRCTs, New Zealand-only, and global lifecycle management
Support for Medsafe approvals and international submissions
Our Working Approach
Requirement Understanding & New Zealand / APAC / Global Scope Finalization
Medsafe & HDEC Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All New Zealand-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 APAC/global acceptance.
Get in Touch – New Zealand Clinical Trial Support
Looking for Medsafe-aligned, New Zealand-compliant Clinical Trial documentation for your pharmaceutical, biotech, or nutraceutical product in New Zealand?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.