TrialTrust – Global Clinical Trial Document Writing & Review Services for Costa Rica
Regulatory-Compliant | Authority-Ready | Globally Trusted
Clinical Trial Documentation Support for Costa Rica & Latin American Submissions
TrialTrust, the scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing, Review, and Regulatory Support Services for Costa Rica-based pharmaceutical, nutraceutical, and healthcare companies, as well as organizations conducting or submitting clinical programs across Latin America and global markets.
We support local submissions to Costa Rican health authorities (Ministry of Health / CONIS) and export-oriented clinical programs, ensuring documentation aligned with national regulations and harmonized with international standards.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects for clients across LATAM, North America, Europe, Asia, Middle East, and Africa.
Who We Are
TrialTrust is a specialized clinical and regulatory documentation partner supporting:
Costa Rican pharmaceutical manufacturers and importers
Nutraceutical & dietary supplement companies
Medical nutrition, functional food & wellness product developers
CROs and export-focused product owners
We specialize in the preparation, independent review, and post-submission query handling of:
Clinical Trial Protocols
Clinical Study Reports (CSR)
All documentation is supported by complete backup data, strong scientific justification, and authority-aligned formats, ensuring inspection-ready and regulator-acceptable submissions.
What We Do
We provide complete lifecycle support for Clinical Trial documentation — from protocol development and ethics approval to final report submission and regulatory authority query closure.
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
Ethics Committee & Costa Rica Ministry of Health / CONIS-ready formats
Alignment with ICH-GCP and LATAM regulatory expectations
📊 Clinical Study Report (CSR) Writing
Full ICH E3-compliant Clinical Study Reports
Clinical data interpretation & conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator, site & subject data integration
Suitable for Costa Rica, LATAM, FDA, EMA, and global submissions
📁 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 review of CT documents
Gap assessment against ICH-GCP, WHO, FDA, EMA, and Costa Rican regulatory requirements
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
Costa Rica Ministry of Health / CONIS / Ethics Committee query responses
Scientific rebuttals & regulatory clarifications
Deficiency letter responses
Follow-up support until regulatory closure
Industries We Serve
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
Export-oriented Clinical Programs
Global Regulatory Alignment
Our Clinical Trial documentation is prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
USFDA
EMA
PAHO & LATAM regulatory frameworks
ASEAN, GCC, African & LATAM MOH requirements
Country-specific Ethics Committee formats
Why Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Dedicated Clinical & Regulatory Experts
✅ Pharma & Nutraceutical Specialization
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Strong Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported globally
Clients across LATAM, North America, Europe, Asia, Middle East & Africa
Experience in new products, line extensions & lifecycle management
Support for local registrations and international submissions
Our Working Approach
Requirement Understanding & Scope Finalization
Regulatory Strategy & Study Design Alignment
Clinical Document Preparation / Review
Internal Quality & Scientific 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 systems, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.