Dr. Anit Singh is a scientific entrepreneur with exceptional medicinal acumen, spirit and a passion to discover, and above all, a commitment to serve the people. He brings on board his vast and varied experiences in successfully completing global clinical trials for pharmaceutical giants like Biogen Idec, Merck, Janssen J&J, Victhom Human Bionics, Wyeth, Mylan, Bharat Biotech and Panacea Biotech among others. In his roles with these organizations he has been instrumental in defining unmet medical need, clinical trials strategy, target indication analysis of market including competition, regulatory strategy, project plan and drug development timeline. He was part of team during successful clearance of audits and inspection by sponsors and regulatory bodies such as FDA, EMEA, WHO, CSIR, CDSCO (DCGI), KFDA, ANVISA and Therapeutic Goods Administration. Dr. Anit has participated in more than 200 trials across the world and has more than 50 publications and abstracts to his candidature. He studied at All India Institute of Medical Sciences, New Delhi and Cleveland Clinic, USA and worked with various agencies like WHO, ICMR, DBT, CSIR and Bill & Melinda Gates Foundation.
Dr. Anit founded Clinical Research Network India, a nationwide consortium of experienced clinicians, expert researchers and clinical research sites that aims to provide expertise and infrastructure support to high level clinical research and accelerate development of life-saving drugs and devices. The Network committed to serve national and international pharma, biotech, medical device, diagnostic, food-nutraceutical, cosmetic industries and contract research organizations. He is instrumental in shaping and leading India’s clinical research industry through International collaboration with various academic and public health associations. His capabilities in instituting strategic alliances among industries have earned distinguished him in the Clinical Trial Industry. He is responsible for overseeing the region’s business operations of the company, new alliances and is focused on stable growth, client satisfaction and long-term relationships.
As a corporate social responsibility, the network dreamed to develop affordable translational health research system for emerging world and touching the lives of millions of people.
anitsingh@crnindia.org, medicalmonitor@gmail.com
Director- Clinical Operations for Clinical Research Network India who acts as a common platform between Investigator and Sponsor for the execution of clinical trials. Over the years she has established to meet the ever-growing performance and quality expectations at the level of clinical trial sites. She understands the hidden pitfalls of clinical trial process for the execution of clinical trial studies in a flawless and time-bound manner. She holds a Doctorate in Pharmacology with master’s in business administration and a bachelor’s in pharmacy. During a career in Biopharmaceutical Industry, she worked with Quintiles, Parexel, Novartis, Eli Lilly, Mylan, Teva Pharmaceutical, Panacea Biotech, Sun pharma Ltd., JSS Research, Torrent, Syngene and Veeda research, among others. She is involved in phase I to IV clinical trials and passionate about clinical project management and getting through regulatory work. She has expertise in almost all major therapeutic areas especially Oncology, Cardiology, Respiratory, infectious diseases etc. She leads the clinical operation group at Network sites and ensures appropriate training, staff performance, development and managing issues apart from developing and maintaining constructive working relationships with KOL, Investigators, sites, collaborators, clients, and service providers. She ensures strict GCP regulations with quality work conduct for clients. During her career in clinical research, she mentored many clinical research professionals, CRAs and Project Manager and making them global leaders for MNCs. Her global experience involves working with US, Europe, China, and Russia and helping companies in product life cycle management including accelerated drug development.
nidhisingh@crnindia.org
Dr. D.M. Ravichand as a medical director at CRN India is a perceptive expert with more than 20 years of clinical research and PVG expertise. He is an independent, free spirited, highly self-motivated individual who takes everyday as a learning and looking out at opportunities to explore newer avenues and learning areas to broaden his thinking canvas.
He has about 200 papers, 10 patents, and has guided postgraduates. His specialities are deriving the strategies and conducting Ethical Clinical research, ICH/GCP Standards, executing the PVG related tasks. He has been a part of clinical trials and PVG and is skilled in making accurate diagnosis and recommending or delivering the right course of action or medication for a variety of ailments. He has also headed AYAAN Institute of Medical Sciences in Hyderabad. He has extreme competence in providing diverse perspective in Pharmacovigilance operations. He has a strong foundation in GCP and other national and international rules, regulatory compliance as well as in the domain of clinical research. Dr. Ravichand has outstanding knowledge and exposure to a wide range of topics related to pharmacology and of drug safety, medical information. Assisted the businesses with the marketing along with his experience in R & D pertaining to the herbal, Pharmaceuticals, Ayurvedic, and nutritional divisions, he gives regular training for all field personnel about good pharmacovigilance practice, mentoring the team members which makes him one of the finest intellectual individuals.
Mr. Yogesh Saini is a clinical researcher with more than 10 years of extensive research experience in field of Life Sciences. He acts as a common platform between Investigator and Sponsor for the execution of clinical trials. He understands the process of clinical trial for the execution of studies in a timely manner and efficient way. He was associated with Sir Ganga Ram Hospital, Medanta The Medicity Hospital and Multi Vaccines Development Program, ICGEB.
yogeshsaini@crnindia.org
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