The Pune-based Jehangir Clinical Development Centre Pvt. Ltd (JCDC) has now been accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. JCDC by earning AAHRPP accreditation, has taken the lead in demonstrating a commitment to safe and ethical research,” said Dr. Marjorie A. Speers, president and CEO, AAHRPP.
PUNE: The Jehangir clinical development centre (JCDC), a research centre at the Jehangir hospital, was chosen as the best research site‘ during the annual award function of the Indian Society of Clinical Research, held in Bangalore on August 27. Cancer specialist Shona Nag represented the centre during the function.
Nag and JCDC have completed nearly 45 phase I to IV global/Indian clinical trials for malignant cancers. Nag initiated a study to understand the root cause of breast cancer in over 1,000 Indian women. The study was funded by pharma major, Glaxo-Smithkline, under its Oncology international ethnic research initiative.
Jehangir Clinical Development Centre (JCDC) is the research arm of Jehangir Hospital, Pune, India. The hospital has over 350 beds, servicing patients throughout Pune and beyond. It has a wide range of disease-area specializations, including, but not limited to: cardiology, oncology, endocrinology, pediatrics, rheumatology, dermatology and infectious diseases. JCDC has over 60 principal investigators and conducts on average 25-30 clinical studies at any point of time.
The recent COVID-19 pandemic offered a rich opportunity to healthcare and the pharmaceutical industries in contributing towards patient care. However, with the opportunity came unforeseen challenges. The clinical research industry was also in a vulnerable position. Conventional methods of conducting clinical trials were interrupted in ways never seen before. Multiple factors like subject recruitment, retention, conducting visits, safety of trial subjects, protocol compliance, data monitoring etc. made functioning of the clinical research industry very challenging. This compelled regulators and the industry to think about the non-conventional yet ethical and economical means of conducting clinical trials without affecting the data integrity and patient safety.
Pathik Divate is a Chartered Accountant and MBA from Thunderbird – The Garvin School in USA. In his 20 years of work experience, Pathik has worked in three industries and across six countries. He is the co-founder of Jehangir Clinical Development Centre Pvt. Ltd. (JCDC) which is a well-established clinical research centre in Pune. Under his leadership, Pathik has taken JCDC from a five people team in 2007 to over 80+ people currently and acquired numerous accolades including the best research centre award by ISCR. JCDC works with over 70+ clients including all the top 10 pharma companies worldwide. Moreover it works with nutrition, consumer healthcare companies, start-ups and public health institutions such as the WHO.
CEO of Jehangir Clinical Development Centre (JCDC), Pathik Divate was conferred with the “Top 100 Healthcare Leaders” award for his contributions to the healthcare industry at IFAH — International Forum on Advancements in Healthcare (formerly known as the Smart Health Conference). The international conference was held at Le Meridien, Dubai on December 16–18, 2019.
CEO of Jehangir Clinical Development Centre (JCDC), Pathik has taken JCDC from a team of 5 in 2007 to over 500 people in the present day. The organization has won numerous accolades including the “Best Research Centre” award by ISCR.
India’s top drug regulator has approved the application of Serum Institute of India (SII) to conduct late-stage human trials in the country for the Oxford-AstraZeneca Covid-19 vaccine candidate.
Researchers in Oxford announced last month that their candidate had triggered an immune response in humans against the novel coronavirus in early trials. The Oxford candidate is considered to be one of the global frontrunners for the Covid-19 vaccine, along with candidates being developed by Moderna with the US National Institute of Allergy and Infectious Diseases, and Pfizer with BioNTech.
The four likely sites in Pune are — KEM Hospital and Research Centre at Vadu, Bharati Hospital, Jehangir Hospital and the government-run B J Medical College and Sassoon General Hospital. Of the 10-15 planned sites across the country, at least four in Pune are likely to be involved in human clinical trials of the Oxford University AstraZeneca Covid-19 vaccine. On Monday, the Union Ministry of Health and Family Welfare tweeted that the Drug Controller General of India (DCGI) had given Serum Institute of India the approval to conduct Phase 2 and 3 clinical trials of the Oxford University AstraZeneca Covid-19 vaccine (COVISHIELD).
Clinical trials form the crucial step in the drug development process. These are essential for development and marketing of the novel therapies for treating, screening or diagnosing a disease or a condition. JCDC is a reputed Contract Research Organisation (CRO) based in Pune with extensive experience in the field of clinical research. We present five key drivers which, in our opinion, are required to be critically looked upon to successfully conduct a clinical trial.