Clinical Development Services Agency
An extramural unit of Translational Health Science & Technology Institute
Dept. of Biotechnology
Ministry of Science & Technology
Government of India
Dr. Monika Bahl, MBBS, MBA, Director Clinical Portfolio Management
Dr. Monika has joined CDSA as the Director Clinical Portfolio Management. A graduate in medicine with additional specialization in human resource management, she brings with her over 16 years of experience in clinical practice and clinical research including project planning, clinical monitoring and project management for in-house and outsourced clinical research projects. She has substantial experience of managing projects in varied therapeutic indications including immunology, pain management, cardiovascular, respiratory, dermatology, psychiatry and diabetes mellitus in previous assignments in Indian and global pharmaceutical / Biotech industry (Ranbaxy Research Laboratories, Dabur Research Foundation, Panacea Biotec, Quintiles).
She has been associated with clinical studies in paediatric, adult and geriatric populations including mega-trials for DCGI/FDA/BfArM submissions. Her responsibilities have spanned from project planning, protocol designing, CRO selection and project management for the full duration of studies from pre-trial to project close-out, medical monitoring, data review and related medical writing. She has significantly contributed to training and mentoring programs for performance improvement and for quality management initiatives on individual, project and organizational level.
Dr. Sucheta Banerjee Kurundkar, Ph.D., Director Training
Dr. Pawandeep Kaur, MBBS, MD (Pharmacology), Associate Medical Director
Dr. Pawandeep Kaur has joined CDSA as Associate Medical Director. A post graduate in Medicine (MD, Pharmacology) she has over 10 years of experience in professing clinical research, clinical practice and as clinical research scientist. She has started her career as Junior resident at Govt. Medical College, Patiala and then as Demonstrator in Anatomy at DMCH, Ludhiana. After her MD in Pharmacology from Govt Medical College, Amritsar; She worked as Clinical Pharmacologist at Escorts Heart Institute and Research Centre, Delhi where she also played a role of member of Institutional Review Board and member secretary of various hospital committees. Before moving to Pharma Industry she worked as Assistant Professor in Institute of Clinical Research India and mentored students for various research projects of Cranfield University, UK. Dr. Pawandeep brings forth good amount of experience in the field of clinical research and development. She has played a crucial role in the development of new drug – through clinical phases and all the way to commercialization. In the process, Her responsibilities have traversed from protocol designing, writing clinical study reports, new drug application and other regulatory documents as well as medical monitoring of clinical trials to ensure GCP compliance. She had been felicitated along with other scientists by Ex-President Dr. APJ Abdul Kalam for her outstanding contribution in development of new drug for malaria. She had presented and published research papers at national and international conferences and journals. A fellow of American College of Clinical Pharmacology, she is also a member of Cochrane Breast Cancer Group, Sydney and Cochrane Back Review Group (CBRG), Toronto.
Dr. Gayatri Vishwakarma, PhD (Statistics), Biostatistician
Dr. Gayatri is a Biostatistician with post-doctoral training in Canada and has 7 years of statistical work experience in academic researches. She started her career as Assistant Statistician in J.N. Agriculture University, Jabalpur moving on to professing Statistics and SAS programming at Amity University, Noida, and Monitoring & Evaluation Specialist in Woodward Charitable Foundation, Ethiopia.
Gayatri is also the Country Representative of two societies (Committee on Women in Statistics and International Association of Survey Statistician) of International Statistical Institute (ISI), Netherlands. She has experience in working with SAS, Stata, R and SPSS. At CDSA, Gayatri will perform statistical analysis and SAS programming for research projects.
Prashant Bhujbal, Finance Manager
Mr.Prashant Bhujbal has joined CDSA as Finance Manager. He did MBA in Finance and also holds a post graduate degree in Agriculture. He has worked for more than 23 years in the Maharashtra Finance and Account Cadre under Government of Maharashtra. As a member of finance Cadre he served on diverse postings in various Government departments ranging from Account, Audit and Procurement of Goods.
Sanjeeva Kumar, Administrative Manager
Sanjeeva Kumar joined CDSA as an Administrative Manager. With a Post-Graduate degree in Human Resource Management from Osmania University, Hyderabad. Sanjeeva has about 15 years of work experience in Human Resource Management & Administration across Infrastructure, Media & Power Sector.
Dr.T.S.RAO, Sr. Adviser Vaccinology and Medical Technologies
Mr. Ramteke retired as a senior drug regulatory officer with 31 years of experience in drug regulatory aspects in the office of the Drugs Controller General of India (DCGI). He has in-depth knowledge of Indian Drugs & Cosmetics Act, Rules and of regulations of Global Drug Regulatory norms. He started his career at Central Research Institute Kasauli in biological-drug testing. He has extensive experience with new drugs, vaccines and biotech products/pharmaceuticals, medical devices approvals and development experience. He also has experience in review and evaluation of product dossier for pre-clinical, toxicological, pharmacological, CMC, and quality control, clinical trial data of new drugs, biological and medical devices (INDs, ANDAs).
He has strong skills in quality assurance management, regulatory oversight of clinical trials, development of SOPs and guidelines and involvement in drug rules amendments. As an expert he has attended various national and international training workshops and meetings on drug regulations. He has contributed to preparation and implementation of Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices. He works as an Expert to the Pharmacovigilance Program, GCP Training and Inspections of CROs in India.
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