Fortis Healthcare has established a comprehensive, quality-driven clinical research ecosystem aligned with the principles of ICH Good Clinical Practice (ICH E6 R2/R3 transition), New Drugs and Clinical Trials (NDCT) Rules 2019 along with subsequent amendments, and the ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants (latest revisions). The research portfolio integrates industry-sponsored clinical trials, investigator-initiated studies, academic/intramural research, and government-funded projects, enabling systematic generation of high-quality, compliant, and globally acceptable clinical evidence. All studies are conducted within a structured governance and quality management framework, ensuring that participant safety, rights, dignity, and well-being remain paramount, with mandatory approvals from Institutional Ethics Committees (IECs), CDSCO/DCGI (where applicable), and other regulatory authorities prior to study initiation, in line with NDCT provisions and ICMR ethical standards.

The organization manages a dynamic and expanding research portfolio comprising interventional clinical trials, observational studies, post-marketing studies, and pipeline projects under regulatory, feasibility, and ethics review. Each study is led by appropriately qualified Principal Investigators (as per NDCT eligibility criteria) and supported by trained research teams, ensuring strict adherence to protocol compliance, ICH GCP requirements, data integrity, and subject protection principles. Compliance indicators across the network demonstrate 100% IEC approval prior to study initiation, timely submission of protocol amendments, serious adverse event (SAE) reports, and continuing review reports, and structured management of regulatory submissions in accordance with NDCT Rules and amendments, thereby ensuring transparency, accountability, and regulatory compliance.

A robust quality assurance and risk-based monitoring framework, aligned with ICH GCP (including the R3 focus on Quality by Design and risk-proportionate approaches), supports all research activities. This includes maintenance of Trial Master Files (TMF) and Investigator Site Files (ISF) in accordance with global regulatory expectations. Regular internal audits, sponsor monitoring visits, and inspection readiness programs are conducted across sites, with systematic implementation and tracking of Corrective and Preventive Actions (CAPA). Data integrity is ensured through adherence to ALCOA++ principles, use of validated electronic data capture systems (including other compliant platforms), and routine source data verification and quality checks, ensuring traceability, reliability, and audit readiness.

Participant protection, safety oversight, and ethical conduct remain central to the research framework. Timely reporting of Serious Adverse Events (SAEs) is ensured within stipulated timelines to sponsors, IECs, and regulatory authorities, in accordance with NDCT provisions and amendments, including causality assessment and compensation reporting where applicable. The informed consent process is conducted in strict compliance with ICMR guidelines and NDCT requirements, including audio-visual recording of consent for vulnerable or applicable studies, documentation of re-consent, and safeguarding equitable participant selection. Continuous GCP training, NDCT awareness, and ethics training for investigators and research staff further strengthen institutional compliance and capacity. Collectively, these measures ensure that Fortis Healthcare delivers ethically robust, scientifically rigorous, regulatory-compliant, and patient-centric clinical research, contributing meaningfully to the advancement of evidence-based healthcare and public health outcomes.