By Ben Adams
BioClinica's appetite for pacts shows no sign of abating as it announces a new tie-up with Japanese CRO EPS to focus on risk-based monitoring in clinical trials.
The Princeton, NJ-based CRO says EPS will use its Compass technology and professional services as its new risk-based monitoring (RBM) solution for clinical trials in Japan. Financial details were not disclosed.
"We are thrilled that EPS, with a reputation as Japan's most progressive CRO, has chosen BioClinica to pioneer RBM," BioClinica Senior Vice President Andrew Masters said in a statement.
Hisashi Tanaka, EPS' president and representative director, adds that his company has been "eager to implement effective RBM services consistent with MHLW/PMDA, FDA and EMA initiatives," specifically one that is "capable of handling our volume and diversity in studies."
Tanaka explains that he chose BioClinica because its ability to track and visualize "at the study and site level, combined with robust alert and action recommendations, stood out over competing systems in extensive evaluation and sandbox testing."
RBM is a labor-intensive process that makes up much of the cost of running a trial, as it is essentially keeping tabs on everything the study does. Its importance is only increasing as regulators such as the FDA and the EMA are looking for biopharma companies and CROs to build more robust RBM programs into their trial designs.
It also comes in the same month that one man died and 5 others became seriously ill after taking a new drug in a private laboratory run by Portuguese company Bial in Rennes, France, highlighting the importance of monitoring risk accurately in studies.
BioClinica's Compass platform is designed to focus study resources on the sites most likely to pose risks to its overall success, managing time and effort in the monitoring process.
The implementation of BioClinica Compass and its other RBM services for EPS is underway, with the technology "rolling out on live studies in coming months," according to a statement from the CRO.
In May last year, BioClinica signed a deal with consulting firm Kinapse to help spread the adoption of its Compass technology.
In fact, this is now BioClinica's 6th deal in the past 18 months and comes just one week after the company acquired clinical trial financial specialist Clinverse for an undisclosed sum.
- read the statement