A Dublin firm, Clinical Trial EndPoint (CTEP), has launched an electronic data capture system for observation studies, where patients’ experiences of newly released drugs are recorded, allowing significant cost reduction.
The clinical research system, RealWorld-EDC, is designed for fast and effective data collection by general practitioners, clinical researchers and nurses collecting data on patient experiences while meeting the most rigorous international standards.
It was launched in Germany last month and will be available to pharma and clinical research companies in Ireland from next week.
The big advantages of RealWorld-EDC are that it is web-based, particularly applicable to Phase IV trials and tailor-made for ‘real-world’ observation study. In addition, it is flexible and scalable, as well as being easy to use with minimum training required, according to Stephen Dorman, managing director of CTEP.
The company, which has 12 employees at Dublin’s Citywest, is one of only 10 global companies to secure international accreditation for its software.
Efficiency and cost-effectiveness
The new RealWorld-EDC software, which cost €1.2m to develop, is aimed at pharmaceutical companies and contract research organisations seeking efficiency and cost effectiveness in a competitive industry.
“Our new web-based software comes at the ideal time,” said Dorman. "Health reforms in nearly all major countries are forcing research-based pharma companies to work and produce at significantly lower costs.
“This is the only way to ensure profits while controlling costs to ensure sufficient financial resources to continue with research and new medicine discoveries."
Earlier this month, the company briefed the Minister for Research and Innovation, Seán Sherlock, TD, on the world-class features of the clinical trial software.
“This is a very good example of an innovative Irish company developing a world-class product which will appeal to global pharmaceutical companies. Concentrating on post-release drug impact studies, CTEP has developed a lower-cost, faster and easier-to-use product with less risk of human error in recording patients’ reports,” Sherlock said.