In the scramble to harness technology to implement risk-based monitoring (RBM) strategies, BioClinica, a provider of technology-enhanced clinical trial management solutions, is acquiring Blueprint Clinical, a small Washington-based developer of Compass, a specialized software program that evaluates potential risks to patient safety and clinical trial operational performance.
Terms of the purchase were not disclosed.
Compass is a proprietary data-driven decision engine with a cloud-based risk assessment reporting capability that is being added to BioClinica’s e-Clinical platform. The Blueprint software assigns a performance-based score to each investigative site based on a combination of quantitative and qualitative information.
“The basic concept for having Compass is that you can use data and analytics to better understand the risks associated with remote monitoring without examining every piece of data,” said Mark Weinstein, BioClinica president and CEO. “This gives users a better way to implement risk assessment methods as part of a comprehensive RBM strategy. Blueprint Clinical has been at the forefront of algorithm development with techniques, which will now be part of our eClinica offerings going forward.”
BioClinica’s acquisition follows the FDA’s final guidance to industry last year that included encouraging sponsors to better use electronic systems to improve clinical insights, avoid risk of data quality and ensure patient safety.
RBM uses off-site and centralized monitoring, instead of on-site monitoring, and partial source data verification. A major goal for users of RBM is to better deploy resources across clinical trials based on specific risk levels. That includes reducing monitoring resources while maintaining data quality and patient safety.
“Compass is an intelligent monitoring solution that replaces 100% source data verification with greater use of off-site and central monitoring,” said Courtney McBean, co-founder and president of Blueprint Clinical, which has worked with sponsors from small biotech to large pharma.
She said the software leverages data from a sponsor’s existing Electronic Data Capture and Clinical Trial Management Systems. McBean and her Blueprint Clinical team will join BioClinica and direct the Compass implementation in its eClinical Solutions programs.