Clinical Research and Development

The Clinical Research and Development (CRD) team, which comprises of graduates and post-graduates from medical, pharmacy and allied sciences is responsible for the clinical development of NCEs and phytopharmaceuticals and providing inputs for various drug discovery projects. 

Clinical Development and Medical Affairs is responsible for the conceptualization, design, conduct, analysis, evaluation and reporting of clinical studies carried out with the NCEs & phytopharmaceuticals in India and other countries. This group includes Clinical Leaders for 4 distinct therapeutic areas – Oncology, Metabolic disorders, Inflammation and Infectious Diseases. The Clinical Leaders interact with the preclinical development groups giving inputs for the clinical development plan. They play an important role in the development of clinical study protocols, and other trial-specific documents such as Investigators’ Brochures, Informed Consent Forms, Case Record Forms and Clinical Study Reports. Clinical Leaders (Medical Monitors) support the Clinical Operations team in conducting the clinical trials across different investigative sites and address queries from investigators, Ethics Committees and regulatory authorities related to applicable therapeutic areas, protocol implementation and safety of the subjects.

The planning, resourcing, implementation, logistics and overall conduct of clinical studies in India and in other countries is managed by Clinical Operations. This is effected either through in-house capabilities or through collaboration with CROs. Clinical Operations is responsible for budgets, timelines and project deliverables for which it interfaces with the Project management teams.

The Pharmacovigilance group is responsible for overseeing the safety profile of new drugs in clinical trials along with continuous assessment of risk-benefit profile of marketed products. The group reports on safety concerns and issues recommendations for compliance with applicable safety regulations worldwide.

The Biostatistics and Data Management group ensures that appropriate methodologies, processes and tools are used for the compilation, analysis and reporting of clinical trial data to support a robust regulatory application.

The Medical writing team supports the Medical Affairs team to develop clear, concise and scientifically accurate study-specific documents in strict accordance with current regulatory guidelines.

The functioning of the CRD unit is based on strong SOPs, and regular quality checks ensure a fully auditable system.

Locations of our Clinical Trials