Challenges And Opportunities In Clinical Data Management

Breakthrough medical interventions are nothing without accurate, comprehensive clinical trial data. Without such data, pharmaceutical and biotech companies are unable to provide the safety and efficacy validations needed to bring therapeutics to market and to the patients who need them.

Unfortunately, in today’s high-pressured, fast-paced clinical development environment a huge challenge exists with the cleanliness, completeness and quality of clinical trial data. Clinical teams are spending valuable time cleaning data rather than analyzing it. The time wasted reconciling clinical trial data issues is detrimental and costly and can result in anything from small delays through to catastrophic setbacks that necessitate reruns of clinical trials. This challenge will only become more difficult to navigate as the volume and variety of data and data sources continue to increase.

To explore these issues and their impact, Pharma Intelligence and Oracle Health Sciences surveyed professionals involved in clinical data management at large pharma companies, biotechs, device developers and CROs based around the world.

The research provided valuable insight into operational issues around clinical trial data, quality issues related to clinical data and the implications of these issues, and a view into what this audience thinks the most urgent data issues will be five years from now.