CTEP directors, (from left) Tomas O'Mahoney, Stephen Dorman and Steve Tee (right) show their new clinical trial software to Minister for Research and Innovation, Sean Sherlock, TD, (second from left) in Dublin.
A young Dublin medical software company is working with 15 major pharmaceutical companies in deploying state-of-the-art software that is making it more cost effective to gather post-release drug research from doctors and nurses.
Clinical Trial EndPoint (CTEP) is one of only 10 global companies to secure international accreditation for its software that simplifies the gathering of patient information by doctors and nurses so pharmaceutical firms can monitor product safety and performance.
The Citywest-based company has signed deals with Abbott and Novartis in recent weeks, and its technology is currently being used by doctors and nurses in the Netherlands, Germany, Austria and Ukraine for clinical trials.
The software is so simple to use that clinicians can use it on iPads or iPhones to provide secure data transmission to pharma organisations and contract research organisation (CROs).
Changing the game
CTEP’s managing director Stephen Dorman told Siliconrepublic.com the pre-registration sector it was targeting has traditionally been dominated by a number of major software giants, most notably Oracle, which recently acquired its next major competitor Phase Forward a year ago.
“We would see ourselves as stealing a lead in the late-phase segment,” Dorman said. “We’re the only company that has specifically developed our software for the post-release space.”
He said the company’s RealWorld-EDC software is the first clinical trial application to offer its own web-based learning programme to go with the global CDISC Operational Data Model (ODM) standards which comply with the US Food & Drug Administration’s highest data-capture standards.
The key advantage of RealWorld-EDC is that it is web phased and particularly applicable to Phase IV trials and tailor-made for real-world observational study.
“We are already working with 15 different pharmaceutical companies in Ireland and Europe, so we walk the talk and that stands to us when we work with international CROs.
“We are currently in discussions with a large CRO in the US. The opportunity is huge and we’re in a good place at a good time to capitalise on the opportunity.”
The opportunity is being driven by the need for pharmaceutical companies to ensure that drug products perform satisfactorily when released into the market and that anomalies can be discovered as soon as possible.
“How drugs perform in the real world can be different from traditional post-trials,” Dorman said, pointing to the drug removals from the marketplace, such as Merck’s decision to remove anti-arthritic drug Rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use.
Dorman says that CTEP, which employs 12 people, is already profitable and it has invested €1.2m in developing its software. He said that in order to scale the business and capitalise on the global opportunity, further funding will be necessary.
“Pharmaceutical companies globally are hurting because of the global downturn. Plus there’s the double whammy of patent expiries and governments being unwilling to pay for expensive drugs.
“It’s a good time because we can go in there and save CROs and pharma firms 50pc off the cost of the traditional software that would have been used in this market,” Dorman added.
