TrialTrust Global Clinical Trial Document Writing & Review Services in Colombia
Regulatory-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 delivered 330+ clinical trial documentation projects for sponsors, CROs, and manufacturers across Colombia, Latin America, Asia, Europe, Middle East, Africa, and global markets.
We specialize in the preparation, review, and post-submission support of Clinical Trial Protocols and Clinical Study Reports (CSRs), supported by robust scientific data, strong clinical justification, and regulatory-aligned documentation suitable for INVIMA submissions and Latin American regulatory authorities.
Our Services for Clients in Colombia
🧪 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 & INVIMA-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, USFDA & INVIMA requirements
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
Responses to INVIMA & Ethics Committees
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support until closure
Industries We Serve in Colombia
Pharmaceutical Finished Dosage Forms
Generic & Branded Medicines
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Export-oriented clinical programs
Colombia & Latin American Regulatory Alignment
Our Clinical Trial documentation is prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
INVIMA regulations
USFDA & EMA reference standards
Country-specific Ethics Committee formats
Why Companies in Colombia Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Experienced Latin American & Global 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 Colombia, Latin America, Asia, Europe & Middle East
Expertise in regulated Latin American markets
Support for local Colombian registrations and regional 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 management systems, version control, and data integrity practices, ensuring regulatory confidence and Latin American acceptance.
Contact TrialTrust in Colombia
Looking for reliable, INVIMA-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 Colombia.