Bioclinica Provides Risk-Based Monitoring Solution in Japan

EPS to Run Clinical Studies Using COMPASS  

DOYLESTOWN, Pennsylvania, Jan. 25, 2016 /PRNewswire/ -- 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.  

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"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. 

Find out more about Bioclinica and its eHealth solutions at www.bioclinica.com, and on Twitter at http://twitter.com/bioclinica.

About EPS Corporation
EPS is a 100 percent subsidiary company of EPS Holdings Inc. (TYO: 4282) and part of a large organization within the EPS Group. EPS is one of the leading companies of CRO (Contract Research Organization) services providing full support – from the planning of clinical trials to post-marketing surveillance – for the development pursuits of pharmaceutical companies, in Japan. 

Learn more at http://www.eps-holdings.co.jp/en/about/network.html and http://www.eps.co.jp/. 

About Bioclinica
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. The Company serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia.

Learn more at www.bioclinica.com.