Participant Safety First
Participant rights, safety, and well-being are the primary considerations in all trial design and conduct, with safeguards proportionate to risk and complexity.
India's most trusted multispecialty hospital operates a purpose-built Clinical Research Centre and has conducted over 85 National, International and Government-funded Phase II–IV trials across 15 therapeutic areas, delivering participant-first care since 2003
Clinical trials at KG Hospital align with ICH-GCP E6(R3) principles, applying risk-proportionate oversight to protect participants, ensure data integrity, and sustain inspection readiness. Our 52-year legacy of advanced, compassionate care strengthens every aspect of trial conduct.
Participant rights, safety, and well-being are the primary considerations in all trial design and conduct, with safeguards proportionate to risk and complexity.
All clinical trials adhere to the Declaration of Helsinki, applicable Indian regulations, and continuous Ethics Committee oversight throughout the trial lifecycle.
Trials are conducted with well-defined, scientifically sound protocols ensuring reliable, interpretable, and meaningful data generation for global regulatory submissions.
Trial processes and controls use risk-proportionate approaches, focusing resources on participant safety and data reliability across design, conduct, and reporting.
Qualified investigators and staff conduct trials under clear Principal Investigator oversight ensuring regulatory compliance and clear accountability for all procedures.
Informed consent is obtained prior to study procedures in full accordance with ethical and regulatory requirements, ensuring voluntary and fully informed participation.
Investigational products are managed in compliance with protocol, GCP, and regulatory requirements — maintaining integrity from receipt through dispensing and reconciliation.
Trial data integrity is maintained in accordance with ALCOA+ principles. Essential documents are preserved to support GCP compliance and inspection readiness at all times.
Adverse events are managed and reported per protocol and regulatory requirements, with transparent sponsor communication maintained throughout the trial lifecycle.
KG Hospital's clinical research programme is backed by the infrastructure, credibility, and patient reach of one of India's most decorated multispecialty hospitals — giving sponsors access to large, diverse participant populations with world-class medical support on-site.
Explore our clinical research journey — from investigator teams to participant care, protocol conduct, and the people who make world-class research possible at KG Hospital.
Our research spans 15 therapeutic areas, each led by experienced unit heads and supported by dedicated research staff ensuring protocol-compliant, participant-safe trial execution.
KG Hospital has participated in over 85 national and international clinical trials spanning Phase II through Phase IV, partnering with leading global sponsors including AstraZeneca, Bayer, Bristol Myers Squibb, and Novartis.
| Year | Study Title |
|---|
Our dedicated clinical research facility integrates participant safety, operational efficiency, and regulatory compliance across every zone — from first visit to final archive.
Accurate participant identification, proper visit tracking, and participant safety — the first checkpoint for smooth, compliant, error-free trial entry.
Transparent and compliant billing with clear separation between trial-related costs and routine clinical care expenses.
A safe, comfortable space for research participants awaiting scheduled study procedures.
Central hub for trial coordination, documentation, and study records management.
Dedicated coordinator support for participants, sponsors, and study teams throughout working hours.
Controlled access to study systems and electronic trial data with multi-level security.
Private spaces for ethical consent discussions ensuring fully informed, pressure-free participation.
Secure storage, dispensing, and accountability of investigational products per GCP requirements.
Dedicated spaces for sponsor monitoring, regulatory audits, and DCGI inspections.
Protocol-specific study visits and clinical assessments in dedicated, well-equipped rooms.
Advanced medical supervision for high-risk participants and complex study procedures.
Immediate response and management of adverse events and medical emergencies with full critical care backup on-site.
On-site accredited laboratory for local testing and central lab sample processing.
Protocol-compliant sample preservation with continuous temperature monitoring and automated backup systems.
Full diagnostic imaging capability supporting clinical trial assessments (Department of Radiology).
Controlled storage and long-term archival of regulatory and trial essential documents for audit reconstruction.
Continuous operation of critical research systems ensured through UPS and backup infrastructure.
Ensures ethical conduct and regulatory compliance of all clinical trials through ongoing EC engagement.
KG Hospital has demonstrated sustained inspection readiness with a successful DCGI (CDSCO) site inspection. Our site maintains continuous documentation standards, trained investigator teams, and robust quality systems — ensuring audit-ready compliance at all times.
Multiple successful international sponsor audits from global pharmaceutical companies confirm KG Hospital's alignment with global GCP expectations, ICH-E6(R3) requirements, and NDCT Rules 2019 — building sponsor confidence for regulatory submissions worldwide.
As a NABH-accredited hospital with NABL-accredited laboratory services, KG Hospital's quality management system provides the foundational infrastructure for GCP compliance — from patient safety protocols to sample handling integrity.
Comprehensive reference documents for participants, collaborators, and research teams — spanning GCP guidelines, regulatory frameworks, and participant rights in English and Tamil.
Whether you are a global sponsor seeking a high-performing South Indian investigative site, a CRO looking for a reliable partner, or a patient interested in accessing cutting-edge therapies — we welcome your inquiry.
Get In Touch