Dr. Vidushi Gupta is a physician scientist and working as Head Clinical Science in Clinical Developmental Service Agency (CDSA) at Translational health Sciences and Technology Institute(THSTI). Her research interests is to work on hypothesis driven studies that bridge the gap between clinical epidemiology and biology to understand complex childhood diseases with special focus on neurodevelopment that have public health importance with the ultimate aim to develop knowledge based interventions and public health tools.
She started with her research career as a senior research officer in multinational phase III trial looking at role of zinc given in early life and its effect on sepsis, and gained experience of planning and executing a randomized clinical trial, she has experience of working with India TB research Consortium, which is a flagship program for TB research at Indian Institute of Medical Research (ICMR) where she worked in four thematic areas of research on TB, Epidemiology &implementation Research; Diagnostics; Therapeutics; Vaccines, and was involved in planning and execution of large multicenter TB vaccine trial.
She has experience of large multisite cohorts and has successfully completed a WHO sponsored, multicounty, multisite cohort study for severity of COVID-19 in children.
She is also a part of the one of the largest pregnancy cohort Inter-Institutional Program for Maternal, Neonatal and Infant sciences: A translational approach- interdisciplinary Group for Advanced Research on BirtH outcome – DBT India Initiative (GARBH-Ini) and coordinating the second phase of this cohort (GARBH-Ini –II Birth Cohort) which is following up children born to pregnant females enrolled in phase-I with a hypothesis that growth and development from birth till two years of age will be associated with antenatal, perinatal and postnatal determinants.
Email:vidushi@thsti.res.in
Phone: 0129-2876460
Dr. Pritish John is a medical doctor with 17+ years of techno-commercial experience across CRO’s, Bio-Pharmaceuticals, SMO’s and Academic institutes with past engagements with companies like Novartis, IQVIA, Johns Hopkins Hospital, National Institute of Tuberculosis and Lambda Therapeutics Research.
Dr. Pritish completed his medical training from India and holds a Master’s in Healthcare Management from Johns Hopkins University, USA. He is a Certified Scrum Master (CSM), Certified Lean Six Sigma Black Belt (LSSBB) and Certified Clinical Research Professional (CCRP).
He has worked over multiple therapeutic areas in design, conduct, recording and reporting of Phase I, II, III and IV clinical trials for NME’s (NCE and NBE). His expertise lies in Clinical Trial Management and Operations, Clinical Trial Monitoring, Clinical Development, Healthcare/Pharma Consulting, Agile Project and Program Management, Process Improvement, Process Excellence, and Clinical Research Training.
Email:pjohn@thsti.res.in
Phone: 0129-2876457
Dr Neha Chawla is a dentist by training, and has completed her post-graduate training in
public health (MPH) and Health and Human Service Management. She has worked with the
Cancer Council Victoria (Australia) in the Forgotten Cancers Project. She has also
contributed in the development of a survivor’s wellness programme in Australia (SWELL).
She joined CDSA in 2018. She continues to be one of the key members involved with
projects and resources built by CDSA, THSTI to help strengthen the clinical research
ecosystem in India (including the Clinical Trials Toolkit for India, the Electronic Ethics
Committee application and M.Sc. Clinical Research).
Her primary research interests include: ethics in clinical research and public patient
involvement in clinical trials.
Email: neha.chawla.cdsa@thsti.res.in
Ms. Vineeta Baloni, Head – Data Science, holds a master’s degree in computer science and a bachelor’s degree in systems management. She also earned her professional qualification in clinical research and clinical data management and acquired additional specialization in personnel management & human resource development.
She has technical and administrative experience of more than 19 years in the fields of clinical data management and information technology from various organisations with a great deal of involvement in procurement, people management, and administration.
She has substantial experience of managing data management projects in various therapeutic indications. She has been managing and leading the clinical data management component of the clinical research projects since its inception to completion. This includes the study setups in the systems to database lock and data archival as well as the operational aspects and regulatory requirements for data management setup.
She has expertise in various clinical data management and monitoring platforms and is accountable for the procurement, setup, and validation of data management systems. She is responsible for the creation and implementation of standard operating procedures (SOPs). She mentor’s data managers and provides training to the monitoring and research team as and when required.
Email:vineetabaloni.cdsa@thsti.res.in
Dr Nitya Wadhwa is an Senior 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.
Email:nitya.wadhwa@thsti.res.in
