Why Choose KG Hospital for Clinical Research

Principled Research.
Participant-Centred Care.

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 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.

Declaration of Helsinki Adherence

All clinical trials adhere to the Declaration of Helsinki, applicable Indian regulations, and continuous Ethics Committee oversight throughout the trial lifecycle.

Scientifically Robust Protocols

Trials are conducted with well-defined, scientifically sound protocols ensuring reliable, interpretable, and meaningful data generation for global regulatory submissions.

Risk-Proportionate Oversight

Trial processes and controls use risk-proportionate approaches, focusing resources on participant safety and data reliability across design, conduct, and reporting.

Qualified Investigators

Qualified investigators and staff conduct trials under clear Principal Investigator oversight ensuring regulatory compliance and clear accountability for all procedures.

Informed Consent Integrity

Informed consent is obtained prior to study procedures in full accordance with ethical and regulatory requirements, ensuring voluntary and fully informed participation.

Investigational Product Compliance

Investigational products are managed in compliance with protocol, GCP, and regulatory requirements — maintaining integrity from receipt through dispensing and reconciliation.

ALCOA+ Data Integrity

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 Event Reporting

Adverse events are managed and reported per protocol and regulatory requirements, with transparent sponsor communication maintained throughout the trial lifecycle.

India's Advanced Clinical Hospital

52 Years of Being
Tamil Nadu's Most Trusted Hospital

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.

8.5M+
Patients treated — India's largest patient reach for trial recruitment
170+
Specialist doctors across every therapeutic area
98.68%
Patient satisfaction rate — highest participant trust
8
National quality recognitions including NABH & NABL
#1
Asia's first 128-slice CT Scanner — clinical imaging pioneer
Padma
Shri
National honour awarded to Chairman Dr G. Bakthavathsalam
Our Story

KG Research in Action

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.

Therapeutic Areas

Specialties & Trial Operations

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.

Endocrinology
Addressing diabetes, obesity, and metabolic disorders driven by lifestyle transitions and aging populations.
Cardiology
Tackling cardiovascular disease through landmark global trials with leading sponsors.
Neurology
Responding to stroke, epilepsy, neurodegenerative, and neurological disorders associated with aging.
Nephrology
Focusing on chronic kidney disease driven by diabetes, hypertension, and aging demographics.
Ophthalmology
Addressing preventable and progressive vision disorders linked to aging and chronic diseases.
Respiratory Medicine
Responding to asthma, COPD, and respiratory infections influenced by pollution and occupational exposures.
Gastroenterology
Focusing on liver disease and gastrointestinal disorders driven by metabolic conditions.
Dermatology
Addressing chronic inflammatory and immune-mediated skin diseases across all age groups.
Obstetrics & Gynaecology
Addressing reproductive, maternal, and gynecological health needs through ethically sound research.
Pediatrics
Improving health outcomes for children through age-appropriate, ethically protective research designs.
Psychiatry
Addressing the growing burden of mental health disorders across social and environmental stressors.
Urology
Responding to urological disorders associated with aging and chronic systemic disease.
Orthopaedics
Addressing musculoskeletal disorders resulting from trauma, degeneration, and aging populations.
Vaccination
Supporting public health efforts to prevent infectious diseases through rigorous vaccine research.
Oncology
Addressing the rising cancer burden through safe, ethical, and patient-focused clinical research.
Research Portfolio

Clinical Trials Conducted (2008–2026)

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.

YearStudy Title
Infrastructure

Purpose-Built Research Facility

Our dedicated clinical research facility integrates participant safety, operational efficiency, and regulatory compliance across every zone — from first visit to final archive.

Participant Entry & Administration

Participant Registration Counter

Accurate participant identification, proper visit tracking, and participant safety — the first checkpoint for smooth, compliant, error-free trial entry.

Clinical Trial Billing Unit

Transparent and compliant billing with clear separation between trial-related costs and routine clinical care expenses.

Participant Waiting Area

A safe, comfortable space for research participants awaiting scheduled study procedures.

Core Trial Operations Hub

Trial Operations & Documentation Area

Central hub for trial coordination, documentation, and study records management.

CRC Support Desk (9 AM – 6 PM)

Dedicated coordinator support for participants, sponsors, and study teams throughout working hours.

Secure System Access Terminals

Controlled access to study systems and electronic trial data with multi-level security.

Informed Consent & Counselling Rooms

Private spaces for ethical consent discussions ensuring fully informed, pressure-free participation.

Clinical Research Pharmacy

Secure storage, dispensing, and accountability of investigational products per GCP requirements.

Monitoring & Audit Rooms

Dedicated spaces for sponsor monitoring, regulatory audits, and DCGI inspections.

Patient Safety & Clinical Care

Consultation & Assessment Rooms

Protocol-specific study visits and clinical assessments in dedicated, well-equipped rooms.

Medical Oversight Area

Advanced medical supervision for high-risk participants and complex study procedures.

Emergency & Critical Care

Immediate response and management of adverse events and medical emergencies with full critical care backup on-site.

Sample Handling & Infrastructure

NABL-Accredited Laboratory (KG Laboratory Services)

On-site accredited laboratory for local testing and central lab sample processing.

Monitored Freezer Area

Protocol-compliant sample preservation with continuous temperature monitoring and automated backup systems.

Integrated Radiology & Diagnostic Imaging

Full diagnostic imaging capability supporting clinical trial assessments (Department of Radiology).

Essential Documents Storage

Controlled storage and long-term archival of regulatory and trial essential documents for audit reconstruction.

Uninterrupted Power & Infrastructure Backup

Continuous operation of critical research systems ensured through UPS and backup infrastructure.

Ethics Committee Support

Ensures ethical conduct and regulatory compliance of all clinical trials through ongoing EC engagement.

Track Record

Audits & Inspections

DCGI Site Inspection — Passed (September 2022)

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.

International Sponsor Audit Success

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.

NABH & NABL Accreditation Underpins GCP

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.

Educational & Reference Materials

Participant & Collaborator Resources

Comprehensive reference documents for participants, collaborators, and research teams — spanning GCP guidelines, regulatory frameworks, and participant rights in English and Tamil.

For Trial Participants
Participant Rights and Responsibilities (English) Participant Rights and Responsibilities (Tamil) Informed Consent Process (English) Informed Consent Process (Tamil) Compensation in Clinical Trials – DCGI (English) Compensation in Clinical Trials – DCGI (Tamil) Privacy & Confidentiality (English) Privacy & Confidentiality (Tamil) Phases of Clinical Trials (English) Phases of Clinical Trials (Tamil)
For Collaborators & Research Teams
ICH E6(R3) GCP Guideline ICH GCP Training Links New Drugs & Clinical Trials Rules, 2019 (NDCT) ICH GCP vs NDCT Rules — Comparison SAE Reporting Timeline SAE Reporting User Manual SAE Reporting Video Links ALCOA+ Principles in Clinical Research Declaration of Helsinki The Belmont Report The Nuremberg Code Clinical Research Manual v3.0
Frequently Asked Questions

What Patients & Sponsors
Want to Know

Yes. KG Hospital's Clinical Research Centre is ICH-GCP E6(R3) compliant and has successfully passed a DCGI (CDSCO) site inspection in September 2022. The site operates under NDCT Rules, 2019, with continuous Ethics Committee oversight and proven audit readiness for both national and international sponsors.
KG Hospital conducts clinical trials across 15 therapeutic areas: Endocrinology, Cardiology, Neurology, Nephrology, Ophthalmology, Respiratory Medicine, Gastroenterology, Dermatology, Obstetrics & Gynaecology, Pediatrics, Psychiatry, Urology, Orthopaedics, Vaccination, and Oncology — each led by experienced specialist investigators.
KG Hospital has participated in over 85 national and international clinical trials from 2008 to 2026, spanning Phase II through Phase IV studies. These include landmark global trials with sponsors such as AstraZeneca, Bayer, Bristol Myers Squibb, and Novartis.
Participant safety is the primary consideration in every trial at KG Hospital. All studies adhere to the Declaration of Helsinki, ICH-GCP E6(R3), NDCT Rules 2019, and continuous Ethics Committee oversight. Dedicated emergency and critical care facilities are on-site, and adverse events are managed and reported per regulatory requirements.
Sponsors and CROs can contact the KG Hospital Clinical Research team at info@kghospital.com or call 0422-4042121. The CRC Support Desk operates 9 AM–6 PM. KG Hospital offers dedicated monitoring and audit rooms, NABL-accredited on-site laboratory, experienced investigator teams across all 15 therapeutic areas, and a large, ethnically diverse participant pool.
KG Hospital is NABH & NABL accredited, has treated over 8.5 million patients since 1974, and holds multiple national firsts — including being Asia's first hospital to install a 128-slice CT Scanner. With 170+ specialist doctors, 8 national quality recognitions, a 98.68% patient satisfaction rate, and Chairman Dr G. Bakthavathsalam honoured with the Padma Shri, it is Tamil Nadu's most advanced and affordable quaternary-care hospital.
KG Hospital follows ICH-GCP E6(R3) — the most current international Good Clinical Practice standard. Data integrity follows ALCOA+ principles. Investigational products comply with GCP and NDCT Rules 2019. The site maintains DCGI/CDSCO compliance throughout every trial lifecycle, supporting global regulatory submissions.
Get Involved

Collaborate with KG Hospital's
Clinical Research Centre

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
CRC Desk Hours
9 AM – 6 PM
GCP Standard
ICH-GCP E6(R3)
Regulatory
DCGI / CDSCO Compliant