TrialTrust Global Clinical Trial Document Writing & Review Services in Italy
egulatory-Compliant | Authority-Ready | Globally Trusted
Who We Are
TrialTrust, the scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical and nutraceutical products across regulated and semi-regulated global markets.
Since 2008, we have successfully supported 330+ clinical trial documentation projects for clients across Europe, Asia, the Middle East, Africa, and LATAM.
We specialize in the preparation, review, and post-submission support of Clinical Trial Protocols and Clinical Study Reports (CSRs), supported by complete backup data, scientific justification, and regulatory-aligned documentation suitable for Italian and EU submissions.
Our Services for Clients in Italy
🧪 Clinical Trial Protocol Writing
Phase I–IV, BA/BE, Pilot & Pivotal studies
Pharmaceutical & Nutraceutical products
Study design, objectives, endpoints & statistical rationale
Inclusion/exclusion criteria & risk–benefit assessment
Ethics Committee & authority-ready formats
📊 Clinical Study Report (CSR) Writing
Full Clinical Study Reports compliant with ICH E3
Data interpretation & clinical conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator and site data integration
📁 Backup & Supporting Documentation
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 technical & regulatory review of CT documents
Gap assessment against ICH-GCP, WHO, EMA, AIFA, & EU regulatory expectations
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
Responses to Health Authorities & Ethics Committees
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support until closure
Industries We Serve in Italy
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
Export-oriented Clinical Development Programs
Italian & EU Regulatory Alignment
Our Clinical Trial documentation is prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
EMA
AIFA (Italian Medicines Agency)
EU Clinical Trial Regulation (EU CTR)
Country-specific Ethics Committee formats
Why Italian Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Experienced Clinical & Regulatory Experts
✅ Strong Pharma & Nutraceutical Specialization
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Comprehensive Post-Submission Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported worldwide
Clients across Europe, Asia, Middle East, Africa & LATAM
Expertise in new products, lifecycle management & line extensions
Support for Italian, EU-wide, and global regulatory submissions
Our Working Approach
Requirement Understanding & Scope Finalization
Regulatory Strategy & Study Design Alignment
Clinical Document Preparation / Review
Internal Scientific & Quality Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All projects are handled under strict confidentiality agreements, supported by robust quality control, version management, and data integrity practices, ensuring regulatory confidence and global acceptance.
Contact TrialTrust in Italy
Looking for reliable, authority-ready Clinical Trial documentation support for your pharmaceutical or nutraceutical product?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation requirements in Italy