Bioclinica Provides Risk-Based Monitoring Solution in Japan

EPS to Run Clinical Studies Using COMPASS  

DOYLESTOWN, Pa., Jan. 25, 2016 – Bioclinica®, Inc., a specialty clinical trials technology and services provider, today announced Japanese CRO, EPS Corporation (EPS), has selected Bioclinica COMPASS technology and professional services as its risk-based monitoring (RBM) solution for clinical trials in Japan.  

“We are thrilled that EPS, with a reputation as Japan’s most progressive CRO, has chosen Bioclinica to pioneer RBM,” said Bioclinica Senior Vice President of Product Development and Technology Andrew Masters. “We provide a complete integrated software solution aimed at satisfying risk-averse CROs and sponsors. This includes giving EPS the ability to track Key Risk Indicators with related tasks and actions across their entire study portfolio. Centralized monitoring with COMPASS is a better, more cost-effective way to monitor clinical trials, and aims to improve site performance and overall study quality.”

“EPS has been eager to implement effective RBM services consistent with MHLW/PMDA, FDA and EMA initiatives − one capable of handling our volume and diversity in studies,” said EPS President and Representative Director Hisashi Tanaka. “From our comprehensive survey of commercially available RBM technologies, we concluded that our RBM services with Bioclinica COMPASS and comprehensive technology and professional services would best meet the intent of RBM, while addressing all three factors critical for successful RBM services  − people, process and technology – together in an RBM SaaS solution with exceptional data integration capabilities.”

Bioclinica offers a feature-rich RBM solution with a library of 44 standard KRIs and an ability to add additional custom KRIs. 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, according to 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.”

Masters explained, “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.”

“We expect our comprehensive RBM solution to make a marked and tangible difference in the ability of EPS to view and manage KRIs,” Masters added. 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.

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 own team,” Masters said. “Bioclinica is shifting the paradigm to technology enablement, making CROs autonomous.”

Implementation of Bioclinica COMPASS and associated RBM professional services is underway with the technology rolling out 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.