Challenges And Opportunities In Clinical Data Management Podcast
Executive Summary
Mike Ward, head of pharma content, sat down with Srinivasa Karri, a strategist with Oracle Health Sciences, to discuss the survey findings and highlight how companies can best manage the torrent of clinical data from multiple sources that will underpin their regulatory submissions.
In September 2018, Pharma Intelligence conducted, on behalf of Oracle Health Sciences, a survey of pharma and biotech executives exploring the challenges and opportunities that the explosion in data sources creates for efficient clinical trial management. Key findings include: For 95% of respondents a huge manual effort is still required to aggregate, clean and transform trial data with two thirds of respondents saying they experience issues with this process; that real-time access to clinical trial data is still not the norm; for 81% of respondents, data governance issues as the biggest challenge with clinical trial data in meeting regulatory compliance; and with the increase in data collected from mHealth sources - such as wearables and smartphones - finding resources that can manage and clean these new forms of data will be the most urgent clinical trial data challenges five years from now.
Mike Ward, head of pharma content, sat down with Srinivasa Karri, a strategist with Oracle Health Sciences, to discuss the survey findings and highlight how companies can best manage the torrent of clinical data from multiple sources that will underpin their regulatory submissions.
A copy of the survey findings can be downloaded here.
Srinivas Karri is a Senior Director of Strategy at the Oracle Health Sciences Global Business Unit. He is responsible for clinical platforms and applications used by clinical trial sponsors to collect, manage and use clinical data as part of the clinical drug development process. He has over 17 years of experience in the field of validation systems, clinical applications and pharmaceutical drug development and manufacturing in a variety of global roles.