eClinical Integration: Challenges & Solutions

8 September, 2015, by ClinCaptureTeam

The use of electronic data collection in clinical trials has been increasing rapidly over the last few years, prompting a rise in the demand for integrated systems. The topic of “systems integration” is widely discussed, but its adoption remains slower than expected. Whether you choose EDC & CTMS, eTMF & Safety, or EMR integration, there is no one-stop-shop solution.

For example, CTMS solutions such as Advanced Clinical Software’s StudyManager have been installed at over 2,000 sites but there are still no defined metadata and communication standards that allow CTMS and EDC solutions to share data. A common issue with EDC-CTMS integration occurs when there are complex investigative site business practices. Most EDC systems only capture clinical trial data through eCRFs that lack CTMS information. Another issue is that some EDCs may lack timeline planning features such as reaching target subject recruitment milestones, for instance. As for eTMF & Safety integration, common issue here is the lack of real-time inspection and ICH/GCP compliance.

With increased regulatory requirements and the trend towards personalized medicine, sponsor companies and CROs need to access more specific solutions to meet their need, making systems integration an increasing necessity for a successful clinical trial. In addition, risk management of the product’s life cycle includes investigators, regulators and patients. This is where systems integration comes in; ensuring data is more accurate and consistent. One way for improving this process is to focus on data analysis, not just warehousing it. Most companies only focus on front-end integration without considering the need to generate reports for regulators later. If data were integrated from the start, it would be easily accessible at any point.

However, this is easier said than done, as implementing systems integration is estimated to cost about $500K and take as much as 3-6 months, which can come up to nearly 10% of the research budget. Such decisions usually come from investors or the company board, which adds extra approval steps for CROs to go through. While the medical and technical staff know the value of data integration, it needs to outweigh some of the drawbacks of the integration process, seen as time-consuming and a costly investment. Collaboration and consolidation among front-end and back-end systems, as well as the emergence of advanced eClinical systems or modules, shows that the value of integrating will grow as users see the efficiency in storing and viewing their data on a single interface.

If you’d like to learn more on the topic, you are most welcome to attend our free Silicon Valley BioTalks event on October 8th in Palo Alto. Panelists would address questions such as: What are the key principles for a successful outcome? What are the new trends and players in place that are tackling the high cost of integrated solutions? Why are eClinical systems vendors and CROs instrumental in making progress and how can they accelerate this process?