TrialTrust Global Clinical Trial Document Writing & Review Services in Bahrain

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 supported 330+ clinical trial documentation projects for clients across the Middle East, Europe, Asia, 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 scientific data, strong clinical justification, and regulatory-aligned documentation suitable for Bahrain and GCC submissions.

Our Services for Clients in Bahrain

🧪 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, USFDA, EMA, NHRA & GCC regulatory expectations

  • Scientific consistency & data integrity checks

🛂 Post-Submission Query Handling

  • Responses to NHRA (National Health Regulatory Authority) & Ethics Committees

  • Scientific rebuttals & clarifications

  • Deficiency letter responses

  • Regulatory follow-up support until closure

Industries We Serve in Bahrain

  • Pharmaceutical Finished Dosage Forms

  • Nutraceuticals & Dietary Supplements

  • Herbal & Botanical Products

  • Functional Foods & Medical Nutrition

  • Generic & Branded Products

  • Export-oriented Clinical Development Programs

Bahrain & GCC Regulatory Alignment

Our Clinical Trial documentation is prepared in alignment with:

  • ICH-GCP (E6)

  • ICH E3 – Clinical Study Reports

  • WHO Guidelines

  • USFDA

  • EMA

  • NHRA Bahrain requirements

  • GCC regulatory guidelines

  • Country-specific Ethics Committee formats

Why Bahraini 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 the Middle East, Europe, Asia, Africa & LATAM

  • Expertise in GCC submissions, regional harmonization & global filings

  • Support for local Bahrain, GCC, and international regulatory submissions

Our Working Approach

  1. Requirement Understanding & Scope Finalization

  2. Regulatory Strategy & Study Design Alignment

  3. Clinical Document Preparation / Review

  4. Internal Scientific & Quality Review

  5. Client Review & Finalization

  6. Post-Submission Authority Query Handling

Confidentiality & Quality Commitment

All projects are managed under strict confidentiality agreements, with robust quality control, version management, and data integrity practices, ensuring regulatory confidence and global acceptance.

Contact TrialTrust in Bahrain

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 Bahrain.