Info & Opinion
December 8, 2016
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Clinilabs, a small Manhattan-based contract research organization (CRO), may have just positioned itself to effectively compete with more established or hulking competitors.
Frustrated with the available software for processing electrocardiogram (ECG) data, Clinilabs connected with the tech company Analyzing Medical Parameters for Solutions (AMPS), also based in Manhattan, to come up with something that not only collects ECG readings from multiple sites, but then helps read, organize and manage them.
Not Out There
Sounds rudimentary, obvious. But it’s not, says Gary Zammit, founder and CEO of Clinilabs, a specialty CRO that focuses primarily on central nervous system and cardiovascular. It also has a core data center.
“In a multi-center trial, lots of ECGs will be coming in from different sites around the world, and those ECGs have to be recorded in a very organized way and attributed to sites’ investigators and ultimately the patient,” explained Zammit. “Right now, the software systems available for managing them are separate from the ones that collect them. You have to integrate one system with another system in order to manage all the ECG files.”
That was wasting time and money for Clinilabs, and ultimately keeping the company from competing well in the space. (One Philadelphia technology firm, eResearch Technology has long had a dominant position in managing ECGs.)
Clinilabs and AMPS designed a more streamlined, integrated ECG analysis program than what they could find in the market. It was a year of letting the AMPS engineers get up close and personal with the work flow inherent in Clinilabs’ cardiac trials; then Clinilabs served as consultants on the interface.
The software, called TrialPerfect 1.0.0, is now complete and is soon to go through validation. Clinilabs won’t own any part of it; they’ll just get “advantageous pricing” since they helped develop it.
But the real upside is that it could position them nicely for competing with bigger CROs. It’s also likely to speed up the movement of data to and through Clinilabs’ core data center, which represents 40 percent of its business.
Clinilabs, launched in 2001, also has a large Phase I research facility. Here is a previous story on the company.
—by Suz Redfearn