TrialTrust Global

Clinical Trial Document Writing & Review Services – Noida

CDSCO-Compliant | Ethics Committee–Ready | Globally Trusted

Trusted Clinical Trial Documentation Partner for Noida

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 companies in Noida and Delhi NCR.

We support Indian regulatory submissions and global filings across Asia, Middle East, Africa, Europe, and LATAM.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects, helping sponsors achieve regulatory acceptance, inspection readiness, and timely approvals.

Who We Serve in Noida & Delhi NCR

We work with:

• Pharmaceutical companies in Noida, Greater Noida & NCR

• Clinical research organizations (CROs)

• Nutraceutical & dietary supplement manufacturers

• Herbal & botanical product companies

• Export-oriented manufacturers targeting regulated markets

Whether your clinical study is India-based or multinational, we ensure documentation meets Indian regulations and international authority expectations.

Our Clinical Trial Documentation Services

🧪 Clinical Trial Protocol Writing

Regulatory-ready Clinical Trial Protocols aligned with Indian and global standards:

• Phase I–IV Clinical Trial Protocols

• BA/BE, Pilot & Pivotal study protocols

• Pharma & Nutraceutical product protocols

• Study design, objectives, endpoints & statistical rationale

• Inclusion/exclusion criteria & risk–benefit assessment

• Ethics Committee & CDSCO-aligned formats

📊 Clinical Study Report (CSR) Writing

Comprehensive ICH E3-compliant Clinical Study Reports:

• End-to-end CSR writing & medical interpretation

• Safety & efficacy evaluation

• Tables, Listings & Figures (TLFs)

• Investigator & site data integration

• Clear clinical conclusions for regulatory submission

📁 Backup & Supporting Documentation

Complete support documentation for Indian and global submissions:

• 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 and regulatory review services:

• Gap assessment against:

  • ICH-GCP (E6)

  • New Drugs & Clinical Trials Rules (NDCTR), India

  • CDSCO / SEC expectations

  • WHO, USFDA & EMA guidelines

• Scientific consistency & data integrity checks

🛂 Post-Submission Query Handling

End-to-end regulatory follow-up support:

• CDSCO / SEC / Ethics Committee query responses

• Scientific rebuttals & clarification documents

• Deficiency letter responses

• Regulatory follow-up until approval or closure

Industries We Support in Noida

• Pharmaceutical Finished Dosage Forms

• Nutraceuticals & Dietary Supplements

• Herbal & Botanical Products

• Functional Foods & Medical Nutrition

• Generic & Branded Products

• Export-driven clinical development programs

Regulatory Alignment & Compliance

All documents are prepared in alignment with:

• CDSCO (India)

• NDCTR, 2019

• ICH-GCP (E6)

• ICH E3 – Clinical Study Reports

• WHO Guidelines

• USFDA

• EMA

• ASEAN, GCC, African & LATAM MOH requirements

• Ethics Committee-specific formats

Why Noida Companies Choose TrialTrust

✅ 330+ Clinical Trial Documents Delivered
✅ Strong Experience Supporting Delhi NCR Pharma Ecosystem
✅ Expertise in Pharma & Nutraceutical Products
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Reliable Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution

Our Experience Footprint

• 330+ products supported globally

• Clients across India, Asia, Middle East, Africa, Europe & LATAM

• Experience with new products, line extensions & lifecycle management

• Support for Indian registrations and international submissions

Our Working Approach

1. Requirement Understanding & Scope Finalization

2. CDSCO & Global Regulatory Strategy Alignment

3. Clinical Document Writing / Review

4. Internal Quality & Scientific Review

5. Client Review & Finalization

6. Post-Submission Authority Query Handling

Confidentiality & Quality Commitment

All Noida projects are handled under strict confidentiality agreements, with:

• Robust quality control processes

• Version control & audit readiness

• Scientific accuracy & data integrity assurance

Delivering regulatory confidence and global acceptance.

Get in Touch – Noida Clinical Trial Support

Looking for CDSCO-ready, globally accepted Clinical Trial documentation for your pharma or nutraceutical product in Noida or Delhi NCR?

Partner with TrialTrust — where clinical science meets regulatory excellence.

📩 Contact us today to discuss your Clinical Trial documentation needs.