by Angela Guess

According to a recent press release, “One of the largest, most in-depth surveys of clinical data management professionals shows that the time it takes companies to design and release clinical study databases is having a negative impact on conducting and completing trials. According to the 2017 eClinical Landscape Study from Tufts Center for the Study of Drug Development, it takes companies an average of 68 days to build and release a clinical study database. Delays in releasing the study database are associated with an increase of nearly a month downstream for other data management processes such as patient data entry and time to lock the database at the end of the study. Respondents that deliver the database after first patient, first visit (FPFV), take nearly twice as long to enter patient data throughout the study and about 75% longer to lock the study database when compared to those that deliver the final database before FPFV.”

The release goes on, “EDC [Electronic Data Capture]  is the most widely adopted clinical application, used by all respondents (100%), followed by randomization and trial supply management (77%), electronic master file (70%), and safety (70%) systems. A majority (58%) of respondents use either Medidata Rave or Oracle Inform as their primary EDC system. When asked about the type of data managed in their EDC, all (100%) CROs and sponsors cite electronic case report form (eCRF) data, followed by local lab and quality of life data (60% each). However, respondents say eCRF data is the highest volume of data they manage in their EDC system (at an average of 78% of the total data managed). The next highest data volumes reported are central lab data and local lab data at 5% each. Remaining data types reported are each 4% or less. This demonstrates the need for processes and systems to support the industry’s vision to have complete study data in their EDC.”

Read more at Business Wire.

Photo credit: Veeva Systems