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Company News Release
eClinical Leader adds Risk-Based Monitoring Technology to Platform
BioClinica, Inc., a leading provider of eClinical Solutions for the Pharmaceutical Industry, has announced the acquisition of Blueprint Clinical, a fast-growing company offering ground-breaking technology and extensive expertise to drive successful Risk-Based Monitoring (RBM) strategies for clinical trials. This move adds Compass, a cloud-based site scoring tool to the robust BioClinica eClinical platform.
By combining the Compass technology with its experience in clinical trial management, BioClinica will now offer a comprehensive “Intelligent Monitoring” solution which will enable pharmaceutical companies and contract research organizations (CROs) to embrace the reduced source documentation approach outlined by the FDA.
BioClinica President and Chief Executive Officer Mark Weinstein said, “Ever since the FDA issued its final guidance to industry on risk-based monitoring last year, there’s been an explosion of interest in technology to make it a reality. Compass provides a transformative risk-based monitoring solution that enables the industry to move forward.”
President and Co-founder of Blueprint Clinical, Courtney McBean added, “Compass is a powerful and proven tool that enables you to monitor what matters, when it matters. It’s an intelligent monitoring solution that replaces 100 percent source data verification with greater use of off-site and central monitoring.”
Compass is used to evaluate potential risks to patient safety and clinical trial operational performance. It assigns a performance-based score to each investigative site based on a combination of quantitative data and qualitative information. It is flexible and adaptable to each sponsors’ needs and is responsive to the complex and dynamic nature of clinical trial designs. Compass accounts for factors unique to the study protocol and investigational drug. Compass provides information that enables sponsors and CROs to adjust their monitoring and focus attention on those sites needing extra support. Among the benefits of using Compass are optimized site quality performance, reduced costs, and effective use of monitoring resources.
Compass leverages data from a sponsor’s existing Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS) whether BioClinica Express, OnPoint, or other eClinical systems. This extends the value of sponsors’ existing investments while supporting integrated monitoring without redundant data collection.
McBean, who will be joining BioClinica with her team to direct Compass implementation remarked, “I am thrilled that the Compass technology is now part of BioClinica’s exceptional eClinical Platform.”
BioClinica is excited to add the Compass product to their Best-in-class eClinical Solutions, including:
· Express EDC: Electronic Data Capture in a web-based solution that creates efficient processes while capturing clean real-time data at the source. Express includes tools for fast-track study build and change management, deep operational visibility, and targeted monitoring.
· OnPoint CTMS: The Office-Smart Clinical Trial Management System that leverages Microsoft applications for the ultimate CTMS experience. It aligns clinical operations and business processes for end-to-end efficiency across the entire trial lifecycle. It provides large-scale user access without expensive licensing fees.
· Optimizer: Powerful forecasting, simulation and demand planning technology for managing global logistics of the clinical supply chain. Optimizer Enterprise Suite includes a streamlined cloud-based tool for essential modeling and planning, a robust desktop solution for extended forecasting and planning, and Aggregator for enterprise demand planning and visibility into the global supply chain.
· Trident IRT: The parameter-driven IRT with unprecedented performance and functionality. It accelerate study protocol setup and deployment and enables study personnel to accomplish complex subject randomization and drug dosing, tracking and reconciliation using a single powerful tool.
Industry professionals can get a first-hand look at Compass and BioClinica’s other eClinical Solutions and Medical Imaging and Cardiac Safety services at the Drug Information Association (DIA) Annual Meeting. BioClinica will provide demonstrations in its exhibit in Booth 1725 at the San Diego Convention Center until June 18.