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Fact Sheet — Genelife Clinical Research

Key facts, figures, and capabilities of Genelife® Clinical Research Pvt. Ltd. — India's CDSCO-registered CRO.

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CDSCO RegisteredCRO/MH/2026/000159
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GCP CompliantICH-GCP Standards
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Global ReachIndia, USA, UK, Europe
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Phase I–IV ExpertiseAll Trial Phases
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16+ YearsClinical Research Experience
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55+ StudiesSuccessfully Completed

Genelife Clinical Research — Company Fact Sheet

2010
Founded
16+
Years as CRO India
55+
Clinical Trials
4
Global Offices
Fact Sheet Genelife Clinical Research CRO India

Experience & Expertise

Genelife boasts over 16 years of experience in the clinical research field, with a portfolio of more than 55 clinical trials across various therapeutic areas. Our team comprises seasoned professionals committed to delivering high-quality research solutions as a trusted CRO in India.

Core Services

  • Phase I–IV Clinical Trials — full-spectrum clinical research from first-in-human to post-marketing
  • BA/BE Studies — bioavailability and bioequivalence study management
  • Regulatory Affairs — CDSCO, FDA, EMA, TGA submissions and regulatory strategy
  • Pharmacovigilance — SAE reporting, signal detection, PSURs, DSURs
  • Data Management & Biostatistics — EDC, CDISC compliance, 99.9%+ accuracy
  • Medical Writing — CSRs, protocols, IBs, regulatory documents
  • RWE & Market Research — observational studies, patient registries, KOL surveys
  • Oncology Support — Withamax™ initiative, supportive care research

CDSCO Registration

CDSCO Registered CRO — Genelife® Clinical Research is officially registered as a Contract Research Organization in India by the Central Drugs Standard Control Organisation. Registration No: CRO/MH/2026/000159

Technology Platform

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Electronic Data Capture (EDC)

Validated, real-time EDC system with 21 CFR Part 11 compliance and comprehensive audit trails.

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eDocumentation Control

Centralized, version-controlled document management for all study-related documents.

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Project Management Software

Milestone tracking, resource planning, risk management, and transparent sponsor reporting.

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Central Randomization System

24/7 online validated randomization — fully compliant with 21 CFR Part 11 standards.

Global Footprint

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Mumbai, India (HQ)

12, Evershine Mall, Chincholi Bundar, Malad (W), Mumbai – 400 064
+91-22-35113379 / 80

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Carson, California — USA

21175 S. Main Street E1 Unit C, Carson, CA 90745

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Cambridge — UK

21 Spalding Way, Cambridge CB1 8NP, UK
+44 7585 707580

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Hamburg — Germany

71, 22523 Hamburg, Germany
+49-163-3243522

Awards & Recognition

  • Top Healthcare Leaders Global Award — World Health and Wellness Congress & Awards
  • Selected among Dynamic Companies in Healthcare during COVID-19
  • Healthcare Excellence Award 2020
  • Achievers Award 2026
  • GENELIFE® Registered Trademark for clinical research and scientific services in India