Clinovo recently hosted the 11th BioTalks on the topic of clinical systems integration at the HP Headquarters in Palo Alto. The panel featured clinical industry experts Carey Smoak (Portola Pharmaceuticals), Lin Wan (Stella Technologies) and Hajime Arnold (Wincere), and was moderated by Clinovo CTO Marc Desgrousilliers. The speakers shared their experience and views around challenges and best practices as well as the recent trends in the field.
One of the important takeaways was that not all systems integration is equal. For example, according to Hajime Arnold, there is much more value in clinical and safety data integration compared to CTMS and EDC due to the fact that safety data reconciliation can be a very costly and error-prone process which affects FDA submission, and can thus be streamlined with the right integrated solution.
Whether a company should integrate or handle using multiple systems depends on its maturity and internal processes in place. However, panelists pointed out that collaboration and consolidation among front-end and back-end systems, as well as the emergence of advanced eClinical systems, shows that the value of integrating is growing as users see the efficiency in storing and accessing data on a single interface.
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. If data were integrated from the start, it would be easily accessible at any point making the data review and cleaning process faster and with higher quality.
In response to the increase in demand, many new players have entered the market in recent years but according to Lin Wan, the industry still lacks innovation as there hasn’t been a breakthrough integration solution yet. In addition, more needs to be done in terms of standardization and availability of open APIs. Panelists also observed the recent trend for real-time clinical integration in order to keep track of study progress. Another recent trend observed in larger clinical trials is the need for integration between EDC, IVRS and central labs.
The challenges of integrating systems include ensuring validation, data security, resource availability and allocation, as well as communication between global teams. For example, panelist Carey Smoak and his former team at Roche Molecular, were able to deliver real-time ad-hoc/monitoring reports using Enterprise Guide to create stored processes, run by non-SAS users using the SAS Add-in to Microsoft Office. They used the SAS Management Console to set up users, groups, roles and permissions. Once the proper users, groups, roles and permissions were created, then the process of creating and running stored processes was accomplished to monitor data in real-time. It took them 6-7 months to finish the project as validation, SAS components and the expertise required were very specific and not included in the traditional SAS programmer role.
In terms of best practices, all panelists agreed that before deciding on systems integration, a business should clearly define its objectives and project management workflow as project tracking is key in ensuring that resources are lined up and deadlines are met. Another crucial step is testing. Integrating systems drains a lot of time and resources so companies should always test and analyze the return on investment, then proceed with training and validation. The project team should also include all stakeholders- end users, PM, researchers and subject matter experts as well as business decision-makers.
Panelists explained that often times, small companies ask for EDC and CTMS integration when risk-based monitoring can be done without a system, on Excel spreadsheets. That is why it helps to work with vendors who understand the clinical trial process versus those that grew in the software world. Some vendors don’t have clinical trial industry expertise and their customers may end up having to implement processes around the system versus using the system to streamline the internal processes they already have in place. Researching the vendor’s customer case studies can be helpful in the decision-making process, for example. And as with everything else, communication is key in ensuring that all sides of the equation are aligned with the same vision.
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