TrialTrust – Global Clinical Trial Document Writing & Review Services
For Pharmaceutical & Nutraceutical Companies in Spain
Regulatory-Compliant | Authority-Ready | Globally Trusted
Who We Are
TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical and nutraceutical products, supporting organizations in Spain for EU-compliant local submissions and global market approvals.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects across Asia, Middle East, Africa, Europe, CIS, and LATAM, ensuring scientific rigor, regulatory compliance, and authority acceptance.
We specialize in the preparation, independent review, and post-submission query handling of Clinical Trial Protocols and Clinical Study Reports, supported by complete backup data, robust scientific justifications, and regulator-aligned documentation.
What We Do
We provide complete lifecycle support for Clinical Trial documentation—from protocol development to final report submission and post-submission authority / ethics committee query resolution—tailored for sponsors, MAHs, manufacturers, CRO-linked programs, and exporters operating in or from Spain.
Our Core Clinical Trial Services
🧪 Clinical Trial Protocol Writing
Clinical Trial Protocols (Phase I–IV, BA/BE, Pilot & Pivotal studies)
Protocols for Pharmaceutical & Nutraceutical products
Study design, objectives, endpoints & statistical rationale
Inclusion / exclusion criteria & risk–benefit assessment
EU CTR / Ethics Committee–ready & Spain-aligned formats (AEMPS & CEIm)
📊 Clinical Study Report (CSR) Writing
Full ICH E3–compliant Clinical Study Reports
Clinical data interpretation & scientific conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator, site & multicenter data integration
📁 Backup & Supporting Documentation
Investigator’s Brochure (IB)
Informed Consent Forms (ICF)
Case Report Form (CRF) review support
Statistical Analysis Plan (SAP)
Literature reviews & clinical justification documents
🔄 Document Review & Gap Assessment
Independent technical & regulatory reviews of CT documents
Gap assessment against ICH-GCP, EU CTR 536/2014, EMA, AEMPS, WHO & CEIm expectations
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
EU CTIS / AEMPS / Ethics Committee (CEIm) query responses
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support until approval or closure
Industries We Serve in Spain
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
EU and export-oriented clinical programs
Global Regulatory Alignment
Our Clinical Trial documentation is aligned with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
EU Clinical Trial Regulation (CTR 536/2014)
EMA Guidelines
AEMPS (Spain) requirements
WHO Guidelines
US FDA (for global submissions)
Country- and ethics committee–specific formats (Spain & EU markets)
Why Spain-Based Clients Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Dedicated Clinical, Statistical & EU Regulatory Experts
✅ Strong Pharma & Nutraceutical specialization
✅ Authority-acceptable & inspection-ready documentation
✅ Proven post-submission query handling expertise
✅ Confidential, accurate & timeline-driven execution
Our Experience Footprint
330+ products supported worldwide
Clients across Asia, Middle East, Africa & Europe
Experience in new products, line extensions & lifecycle management
Support for Spain, EU-wide, and global submissions
Our Working Approach
Requirement understanding & scope finalization
Regulatory strategy & EU study design alignment
Clinical document preparation / independent review
Internal quality & scientific review
Client review & finalization
Post-submission authority & ethics committee query handling
Confidentiality & Quality Commitment
All projects are handled under strict confidentiality agreements, supported by robust quality systems, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.