Tata Consultancy Services
Abhishek Banerjee, currently serving as a Group Lead at Tata Consultancy Services, with over 10 years over Clinical Data Management experience (End to End Activities). Passionate about study setup, leading new CDM related initiatives, and process excellence owner in the project. Apart from work, an avid traveler and Himalayan hiker.
Title of Session: Non-Interventional Studies and Data Management
Description of Session:
Clinical Research & Clinical Data Management has evolved throughout the decades; Research methodologies have changed over the decade, and now there is rise of Non-Interventional/Observational Studies.
Non-Interventional Studies (NIS) scrutinize various aspects of drug use, including efficacy and safety, under real-life conditions per clinical practice. NIS are defined by methodological approach, and not scientific objectives.
Due to the nature of the Non-Interventional studies, it has been observed the overall budgets assigned for these trials are relatively lower than the regular studies. With less budgets involved, there are various cost considerations the Sponsor would consider which makes it challenging for delivering on a tight budget.
These NIS studies are underseen due to the budgets, however at times they prove to be more challenging to handle than the regular interventional studies.
Due to deferent regulations in many different countries, it becomes challenging designing the studies. With the treatment visits per real-life conditions it is also challenging to expect and track on data on the eCRFs. Also the need of reporting all AEs (Both Serious and Non-Serious), making it even more challenging to perform SAE reconciliations.
The presentation, intends to share a few approaches taken for setting up Non-Interventional studies, and sharing the challenges faced with the remediation’s.
About Non-Interventional Studies
Challenges faced by Data Management with Non-Interventional Studies