Key Developments

On February 6, 2024, Mr. Robert Ball, Deputy Director of the USFDA Office of Surveillance and Epidemiology (OSE), announced at the DIA Global Pharmacovigilance and Risk Management Strategies Conference in Baltimore that the FDA is enhancing its pharmacovigilance efforts with artificial intelligence. The FDA's Information Visualization Platform (InfoViP), launched in 2022, uses AI to assist in reviewing adverse event reports, aiming to streamline the process amidst increasing annual reports exceeding 2 million. Additionally, the FDA is piloting standardized Risk Evaluation and Mitigation Strategies (REMS) data to improve accessibility and usability.
In February 2023, Parexel International Corporation, one of the largest clinical research organizations, introduced the Expert Series—New Medicines, Novel Insights, showcasing the latest findings from its interdisciplinary experts. The series presents in-depth analyses of trends influencing drug development, offering evidence-based guidance tailored for the biopharmaceutical sector.
In February 2022, Cognizant, an information technology services and consulting company, forged a collaboration with Medable Inc., a software company, to coalesce efforts in providing clinical research solutions using Medable's software-as-a-service platform tailored for decentralized clinical trials.
In February 2022, LINK Medical, a Contract Research Organization and Regulatory service provider and Viedoc, a software company, formed a partnership facilitated by Viedoc to enhance trial efficiency for LINK Medical and its clientele. This collaboration facilitates ongoing sharing of insights, requirements, and innovations, including the testing of new functionalities.