Dr. Vikram Gota with Dr. Rajiv Sarin, Director, ACTREC & Dr. Surekha Zingde, Dy. Director, ACTREC
The 94 bedded Clinical Research Centre treats over 2000 new cancer patients every year as part of various clinical, translational or biological studies. In the year 2012, a dedicated Phase I Clinical Trial Unit has been established to give further impetus to early clinical development of anticancer and adjuvant drugs. The two deluxe rooms will cater to conduct resource intensive phase I clinical trials and bioequivalence studies initiated by Indian or multinational pharmaceutical industry as well as academic investigators. The unit is supervised by Dr. Vikram Gota, a clinical pharmacologist with training and experience in conducting early phase clinical trials, drug development and pharmacokinetic studies. A team of Clinical Pharmacologists, Medical Oncologists, Pharmaceutical scientists, Clinical Trialists and Bio-Statisticians are responsible for the design and/or conduct of early phase clinical studies. The unit is manned by specialist registrars and research nurses round-the-clock with internal and external audits as per regulatory requirements. Supporting services include an NABL accredited composite lab for routine laboratory investigations, a clinical pharmacology lab with facilities for sample processing and storage, a bioanalytical lab equipped with three High Performance Liquid Chromatography (HPLC) machines, the department of radiodiagnosis and a seven bedded state-of-the-art Intensive Care Unit. ACTREC has an IRB comprised of eminent clinicians and scientists constituted as per ICMR norms, with an average time of 6 weeks from submission to approval.