In the Philly burbs, you can always turn over a stone and find yet another clinical trials tech firm. But most have a unique angle, rather than being merely duplicative.
One such company is CluePoints. which offers a Risk-Based Monitoring and Central Statistical Monitoring solution designed over the last 20 years. CluePoints is growing, and just completed a move from Wayne (where it opened its first US office in 2017) to King of Prussia (1000 Continental Drive, Suite 240) for larger quarters. CluePoints’ base is Belgium.
Risk Based Monitoring (RBM) is a clinical trial-monitoring technique that fulfills regulatory requirements but moves away from 100% source data verification (SDV) of patient data. It employs various tools and statistical measures to determine what is most critical to a trial and what’s not. The idea is to use advanced technology to lessen costs and difficulties associated with trials while maintaining standards.
ICH GCP E6(R2) was adopted in 2017 as an addendum to ICH E6: Good Clinical Practice: Consolidated guideline, adopted in 1996 by the International Conference on Harmonisation. R2 was intended to encourage implementation of improved and more efficient approaches to
clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
CluePoints, which considers itself the leading provider of RBM technology, said in a press release that it has experienced tremendous growth in the past years, “growing from a team of five people in 2012 to currently just over 60, with plans to accommodate 100+ employees [overall] by close of 2019.” It currently has 11 people in King of Prussia, according to LinkedIn.
In a significant partnership recently announced, CluePoints will work with clinical solutions company Parexel in a strategic collaboration to meet global clinical data acceptance regulatory requirements using central statistical monitoring (CSM).