Clinical development analytics--the name for both the technical concept and the software solution that Oracle released last month--concern high-level trial visibility gained by extracting and collating into one view the data from such e-clinical sources as EDC, clinical data management and clinical trial management systems. But neither the concept nor the business intelligence solution are quite there yet, says Ruchi Mallya, pharmaceutical technology analyst for Ovum Health Care Life Sciences, in Ovum's Straight Talk service bulletin.
The difference between CTMS and CDA, she writes, is that CTMS offers visibility at the study level, while CDA provides it at the program level.
"CDA [the Oracle software] is focused on operational reporting and performance metrics on trial management, which is the objective of existing CTMS solutions," she writes. And regarding the CDA concept, she says it's "yet to be seen" whether the performance visibility of a CDA system provides significant ROI over that of a CTMS.
Nick Giannasi, VP at Oracle Health Sciences global business unit, agrees with Mallya that CTMSs are primarily focused on capturing data elements relating to the progress of a study. They are "a huge source of trial management data," he says via email, "but organizations often struggle to exploit this data and use it to optimize studies.
The Oracle CDA software consolidates, aggregates, and repurposes trial data into "a unified performance and reporting platform that can be used from executive to clinical site," says Giannasi. The solution is based on the software giant's Business Intelligence Suite Enterprise Edition Plus, which provides dashboards for "varied roles across the organization," including data managers, clinical research associates and project managers. The business intelligence suite also has an ad hoc report builder that integrates with the CDA data warehouse.
Mallya writes that the CDA solution, coupled with the company's recent acquisition of drug safety solutions provider Relsys and the upgrade of its remote data capture solution, shows that Oracle is tackling "the life sciences industry's costliest processes." She sees the CDA solution as a step in the right direction. "In future releases," she writes, "we hope to see greater synergies between CDA and other transactional e-clinical systems such as EDC."
- here's the Oracle CDA announcement
- read Mallya's analysis