Two Clinical Trial Leaders, ERT & Bioclinica, agree to merge

Tom Paine

A pair of Philly-area leaders in conducting clinical trials, Princeton-based Bioclinica and Philadelphia-based ERT (eResearchTechnology), have agreed to merge.

The transaction will integrate Bioclinica’s expertise in imaging with ERT’s expertise in eCOA (electronic clinical outcome assessments), cardiac safety, respiratory and wearables.

“As our customers continue to transform their R&D operations, we must continuously deliver a breadth of innovative technology and services,” said Joe Eazor, President and CEO of ERT. “Our merger with Bioclinica will allow us to continue to reinvent end-point data collection by delivering higher-fidelity data and more integrated solutions to achieve our customers’ goals for higher effectiveness, greater efficiency, safer trials, and more patient-centric virtual solutions.”

ERT is actually acquiring Bioclinica, though terms were not disclosed.

ERT has 2700 employees per its LinkedIn profile and Bioclinica has 2600 employees, according to an announcement on its website.

European PE firms are the investors behind both companies.

ERT’s investors have been Astorg, Nordic Capital, Novo Holdings, and the company’s management team.

Bioclinica was acquired by Cinven in 2016. Cinven will now have a “significant” minority stake in the combined company.

Covid-19 has shaken up the clinical trials industry, by forcing changes in how trial candidates are identified and where trials are conducted, among other factors.

ERT was hit by a ransomware attack in late September that slowed work for a couple 0f weeks, according to a story in the New York Times.

Soon after, ERT said then- CEO and President Jim Corrigan was stepping down, replaced immediately by Eazor, most recently CEO of Conifer Health Solutions and previously leader of both Rackspace and Earthlink. Its not clear whether the management change was related to the rasonware attact.

Eazor will lead the newly combined companies. The merger should be completed in early 2021, the joint announcement said.

CluePoints is trying to change the game in clinical trials

Patrick Hughes, CluePoints Chief Commercial Officer, is a ClinPhone veteran
(CluePoints website)

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).

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Clinical Trial data leader Medidata, with Conshy office, to be acquired by Dassault for $5.8 billion

It really flies

Tom Paine

Medidata, which calls itself a Unified Life Science Platform, agreed yesterday to be acquired by French technology company Dassault for $5.8 billion in cash, 2% less than its closing price the preceding Friday.

New York-based Medidata, founded in 1999 and specializing in data and processes related to clinical trials, has an office in Conshohocken dating from an acquisition with some 100 employees, per LinkedIn. There is stepped up competition as larger participants enter the market. Medidata revenue increased 17% last year to $635.7 million while it reported net income of $51.9 million.

Other larger entrants in the market include Oracle, Veeva Systems, CRF Bracket (just renamed Signant Health), BioClinica, and IQVIA , the result of the merger between IMS Health and Quintiles.

Dassault had revenue of $3.5 billion euros in 2018. It acquired Quintiq, a supply chain software provider based in Radnor and the Netherlands, for $336 milion in 2014. Rumors about Dassault’s interest in Medidata date back to at least April.

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