- About Us
- CLINICAL STUDY SUPPORT SERVICES
Department of Biotechnology
Ministry of Science & Technology
Government of India
Professor Usha Menon , FRCOG, MD (Res)
Usha Menon is Professor at the MRC Clinical Trials Unit in the Institute of Clinical Trials and Methodology at University College London and Distinguished Professor at Translational Health Science and Technology Institute (THSTI) India. Since November 2017, she has taken on the role on Mentor and Strategy Lead at the Clinical Development Services Agency (CDSA).
Her research to date has focussed on improving outcomes in gynaecological particularly ovarian cancer through risk prediction, screening and early detection. She has over 250 publications in peer reviewed journals. Her work includes one of the largest randomised controlled trials to date – the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) as well as large cohort studies assessing screening in high risk women (UK Familial Ovarian Cancer Screening Study), exploring genetic and epidemiological risk factors (UK Ovarian Cancer Population Study) and symptoms and intervals to diagnosis of cancer (International Cancer Benchmarking Partnership Module 4). The trial biobanks (UKLWC) with over half a million well-annotated samples, support numerous cancer biomarker case control studies and has resulted in a UCL spin-out company.
Dr. Nitya Wadhwa, MD (Pediatrics), Faculty In charge CDSA and Assistant Professor, THSTI
Nitya Wadhwa is an Assistant Professor at the Translational Health Science & Technology Institute (THSTI). Since August 2017, she has been made faculty in-charge of Clinical Development services Agency (CDSA) from THSTI.
She is a Pediatrician by training and has been doing clinical research for more than a decade. Her expertise lies in implementation of hospital based clinical studies especially clinical trials. She has been associated with several large multicentre clinical trials using zinc for treatment of various childhood illnesses, surveillance for H Influenzae B in tertiary hospitals, establishing a large cohort of pregnant women to find solutions for adverse pregnancy outcomes, and observational studies to understand the development and maturation of the neonatal and infant immune system. She is the Principal Investigator for a large multicountry multicentre clinical trial to see efficacy of adjunct zinc for the treatment of young infant sepsis. She is credited with the development of revised guidelines for the management of diarrhoea in children for NRHM (2007). She was member of National Indian Academy of Pediatrics (IAP) for Consensus Guidelines for treatment of Diarrhoea (2006) and Management of Severe Acute Malnutrition (2006). She is instrumental in establishing the data management centre (DMC) at the Pediatric Biology Centre (PBC) of THSTI and runs the DMC for all studies being conducted and coordinated by PBC. She helped establish the Institutional Ethics committee for Human Research at THSTI and in the registration of the IEC with CDSCO. She was the founder member secretary of the THSTI IEC. Her primary research interest is at the interface of young infant and childhood infections, nutrition and immune function. She has authored many publications to her credit including one in Lancet and has co-authored chapters in text books.
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, PhD (Biochemistry), MBA, Director Training
Dr. Sucheta Banerjee Kurundkar has joined CDSA as Director Training in 2012. She has 20+ years of experience in research & CRO Industry. She is involved in training, quality assurance (pre-clinical, clinical & medical labs) & regulatory affairs. She is a GLP Trainer (WHO-TDR); GCP Trainer; GCLP Trainer; Auditor for NABL (ISO 15189, ISO 17025), ISO 9001:2015 & NABH standards. She is a NABH Assessor (Ethics Committee under clinical trial accreditation program) & SIDCER (WHO) Survey Trainee. Sucheta is a Visiting Faculty to Bureau of Indian Standards & National Institute of Training for Standardization. Sucheta obtained her PhD in Biochemistry from University of Pune. Her doctoral work on a novel inhibitor received recognition at the World Congress on Insulin Resistance Diabetes & Cardiovascular Research, USA (2010). She is the recipient of CSIR International Travel Award. She has a MBA with specialization in Total Quality Management from Sikkim Manipal University and Management Development Programme from IIM, Ahmedabad (IIMA). She is an International Program Committee member of IIMA (2015-till date). Professionally trained in ‘Management of Training’ from Institute of Secretariat Training and Management, she has steered >110 training programs with national experts and CDSCO across 50+ Indian cities covering >10600+ participants, >2000+ institutions at CDSA. She is a reviewer to 11 international journals of repute. Sucheta is working to develop e-learning programs on regulations, GCP and ethics. She is an Advisory Group Member to WHO-ICMR-NIE e-course for Indian Ethics Committees (e4IEC). Since 2016, she has been involved in India’s first Comprehensive National Nutrition Survey by UNICEF as a Team Leader for monitoring of biological samples at CDSA.
Ms. Shubhra Bansal, Director – Clinical Portfolio Management
Ms. Shubhra Bansal has joined CDSA as Director, Clinical Portfolio Management. She holds a master’s degree in Medical Elementology and Toxicology and has experience of over 18 years in Biopharmaceutical and CRO Industry (Eli Lilly , Inotek Pharmaceuticals, PPD) with in-depth knowledge of managing and executing global/Indian clinical operations, project management with APAC regional management (India, Japan, Thailand, Nepal, Srilanka, Taiwan, Australia, Malaysia, Philippines, Honk Kong, China and Singapore). She is member of Indian Society of Clinical Research (ISCR) and has also supported the academic researchers and SMEs as an independent consultant with Biotech Consortium India Limited (BCIL). She has been actively involved in development of online platform for clinical research training and the same remains, one of the key area of interest. She has served as part of Indian leadership team in her previous organizations and has wide experience of managing studies and clinical development services (start up, study conduct, study closure, data management, risk based monitoring), phase I – through phase IV, observational studies, post marketing surveillance, in numerous indications including: Lupus, Diabetes, Refractory Partial Seizures, AML, Sepsis, Erectile Dysfunction, Myocardial Infarction, Macular Oedema, Cardiac Bypass, Oncology, Vaccines (Malaria, Dengue), Leishmaniosis and public health research.
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.
Arun Kumar B. Ramteke, Consultant, Regulatory Affairs
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.