In today’s fast paced ‘all or nothing’ innovative solution-focused industry, clinical software repositories and data analytic solutions for data conformance tend to be complex and miles away from empowering the user with flexibility and ease of use. Time after time, users struggle having to manually create programs, tables, and libraries for data conformance, which can be cumbersome as well as increase percentage of human error.
Besides, how many times has a clinical project manager or clinical data manager had to wonder where their latest data sets are from a specific CRO as they near the end of a specific clinical trial? Are the datasets conformed to the correct standards? Which source solution did the datasets come from? How can they manage the metadata and ensure it is validated, along with data quality checks being executed? What about traceability of the metadata, and reusability?
Having a solution with an integrated conformance module, integrated directly within your business analytics and clinical data repository and other modules, hosted on one seamless platform, is the solution. It is also important to have risk based monitoring seamlessly integrated with EDC and/or CTMS solution.
The challenge for clinical software companies is actually making this happen. Facilitating clean data and maximizing the re-usability and traceability of data from a single source of truth with configurable integration for many clients is all but a theory and miraculous vision.
Taking this data even higher and ‘”letting the data out” to make key decisions, measure/compare KPIs and clinical progress, involves high cost and complex manual integrations that are typically cumulative and not incremental.
Most importantly, users need to be able to access their data fast, track significant key deliverables, review data, and make necessary submissions. This access should be secure, and allow users to get this data from any device, anywhere.
Perhaps a platform that allows users to access all clinical & operational data, generate ad-hoc reports, achieve true risk-based monitoring, and analytics in real time, integrate with clinical and data management solutions, all on one platform, will be a true innovative solution with minimal disruption?
The challenge is actually making this happen, but it does not have to be ‘all or nothing’ as mentioned earlier. Instead, it is likely to make more sense to take a layering and building-block approach and work with an existing system. Replace the applications when the opportunity presents itself, experience the benefit, and then move onto the next component of the eClinical system. The same approach should be taken with clinical analytic platforms.