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COMPASS points east to Japan
DOYLESTOWN, Pa.—BioClinica Inc., a clinical trials technology and services provider, has announced that EPS Corporation, a Japanese contract research organization (CRO), has selected BioClinica COMPASS technology and professional services as EPS’ risk-based monitoring (RBM) solution for clinical trials in Japan.
“EPS has been eager to implement effective RBM services—one capable of handling our volume and diversity in studies,” said EPS President and Representative Director Hisashi Tanaka. “When we looked at configurability, ease of deployment, ability to connect to existing eClinical systems and overall flexibility of the solution to meet our needs, COMPASS came out ahead as the RBM enterprise solution for us.”
“We are thrilled that EPS, with a reputation as Japan’s most progressive CRO, has chosen BioClinica to pioneer RBM,” said BioClinica’s senior vice president of product development and technology, Andrew Masters. “Data integration is the backbone of successful RBM analytics. COMPASS was specifically designed to process operational and patient data from EDC, CTMS, RTSM and other source systems with little configuration, providing users the utmost confidence in our RBM analytics.”
As Kristin Mauri, director of global consulting and eHealth solutions at BioClinica, tells DDNews, “COMPASS is a purpose-built, SaaS product designed to assist our clients in managing key risks throughout the trial lifecycle in a proactive and systematic manner. COMPASS provides central visibility into the key risk indicators (KRI) across all of a study’s functional areas and supports onsite, offsite and centralized monitoring activities.”
BioClinica offers the RBM solution with a library of 44 standard KRIs and an ability to add additional custom KRIs. According to Tanaka, tracking and visualization at the study and site level, combined with robust alert and action recommendations, stood out over competing systems in extensive evaluation and sandbox testing at EPS. COMPASS provides study teams with early visibility into site and patient trends for improved data quality and oversight of trials, reducing costs through centralized, technology-enabled monitoring.
“Recognizing that technology alone does not ensure a successful RBM program, Bioclinica has a professional services team which has deep experience in conducting RBM studies and in the transition from traditional monitoring to RBM practices. This team provides a host of services, such as educating organizations on key RBM principles and assisting with KRI selection, best practices and change management—all meant to help prepare the organization for, and to drive toward, efficient RBM implementation,” continues Mauri.
One of the benefits of COMPASS is the ability to avoid potential delays, Mauri adds, saying: “COMPASS gives the study management team a proactive set of tools to manage risk and get ahead of problems before they impact timelines and cause study delays. For example, early issue identification around patient enrollment at the site or study level can provide the team with an opportunity to course correct to avoid missing enrollment milestones. Standard KRIs within the COMPASS system provide this level of risk awareness, and help teams focus on those risks most impactful on a study and the organization’s objectives.”
Study managers, monitors and other EPS team members are participating in a comprehensive training program. “We want to ensure our customers become as adept at using COMPASS as our own team,” Masters said. Implementation of BioClinica COMPASS and associated RBM professional services is currently underway at EPS, with the technology to be implemented on live studies in coming months.
“EPS is looking forward to working with BioClinica in this technologically innovative RBM era to contribute to pharmaceutical product development,” Tanaka said.