The Electronic Data Capture industry is currently experiencing some major changes. EDC is clearly becoming a commodity, more and more companies are moving away from paper-based clinical studies to scaled EDC systems.
Along with that, the Cloud environment has obviously disrupted the market. End users are now able to access their studies from anywhere at any time. The increase in the management of higher amounts of data is very challenging for life science companies that use data capture.
In parallel, the EDC products themselves are evolving. Life sciences companies aim at building adaptive clinical trials along with risk based monitoring. This is why more and more EDC companies are trying to provide eClinical software integration along with their standard offer to fit with the customers’ requirements.
– Technology based approach –
One of the main improvements of the clinical trials’ world concerns the collection of medical data. With the technologies used today, the data quality has definitely been ameliorated. Edit checks and controls are now able to spot mistakes earlier in the process and also at a larger scale than ever before.
Technology also improved the safety level by allowing to manipulate and analyze significantly larger amounts of data points. Computational predictive analyses help the industry players to refine patient candidacy as well as patient safety.
The application of new generation clinical trials analytics, such as visual, self-service, and interactive dashboards will improve the overall operation of clinical trials. These tools not only advance retroactive tracking of results, but further enable proactive decision-making by spotting patient safety issues earlier and faster.
In addition to this, Cloud technologies have drastically changed the way smaller companies address innovative science and patient treatment by allowing access to advanced and sophisticated solutions (higher quality of data and therefore higher FDA success rate) that were only accessible to the large pharmaceutical companies in the past.
– Patient data integration challenges –
Integrating patient data from Electronic Medical Records is a very challenging task for numerous reasons. Physician practices, for example, have a very low adoption rate when it comes to EMRs. The biggest problem however comes from the interoperability between EMR and EDC. The tools provided from vendors to extract data from EMRs are clearly lacking. Moreover, the deficit of standardized payload and method of delivering from different EMRs to the EDC systems enhances that issue. It is therefore very difficult to deal with clinical study subjects that aren’t part of the same health system and therefore the same EMR.
Once that step is overcome, a deficiency sustains in the methods for identifying the same patient in between EMR and EDC systems without even mentioning the inability to map and translate some EMR data sets into case report forms (CRF) of the EDC systems.
These challenges are definitely worth taking into account but the costs of duplicate entry and the associated errors are higher than the costs of establishing the interfaces to the external systems. We, at ClinCapture, are definitely interested in the use cases of the industry players and welcome any dialogue or feedback on this very exciting challenge.
Written by Ale Gicqueau, President and Chairman at Clinovo