Business intelligence software vendor SAS has signed a six-figure deal with the European Phase IV informatics company Eclipse, based in Dublin, which will use a SAS-based electronic data capture technology (EDC) in future clinical trials aimed at discovering wonder drugs of the future.
The discovery and development of a new drug typically costs between €600m and €800m and can take between 10 to 15 years to complete the process. Once developed, pharmaceutical firms can lose up to €1m for every day that a branded drug is not on the market. Speed of data acquisition, analysis and regulatory submission is vital in this context.
Founded in 2001, Eclipse is the leading Phase IV European Clinical Informatics company providing, internet-enabled clinical trials services and solutions to the pharmaceutical, biotechnology and medical device industries. Eclipse uses EDC for optimal management of Phase IV clinical trials. Eclipse’s objective is to enhance the long-term value of clinical research data for marketing and competitive clinical trials. Eclipse is headquartered in Dublin, with offices in US, UK and Continental Europe.
Eclipse recognised that pharmaceutical marketers need quick data intelligence turnaround for publication and campaign deadlines. By combining the SAS-based ECD management solution and Eclipse’s EDC technology, Eclipse can offer major advantages to pharmaceutical firms by saving them up to one third of the time and up to half the costs previously involved in Phase IV clinical trials. To date, these trials have typically involved highly laborious paper based administration, monitoring and analysis. Phase IV trials are essential to pharmaceutical firms seeking to monitor the efficacy, safety profile, market impact and lifecycle of drugs in use.
Eclipse employs an EDC system for optimal management of Phase IV clinical trials. The key differentiator provided by Eclipse, is that the studies are web-based which removes the traditional paper and time intensive approach that normally requires masses of manual labour. By streamlining this process, Eclipse can provide reduced set-up effort and turn-around times to their customers. In addition, by processing all the studies in SAS, Eclipse are also ensuring they meet all the US Food and Drug Administration (FDA) requirements effortlessly.
“Our EDC technology ensures the process of collecting data in Phase IV trials is faster, thereby giving our clients earlier data to develop marketing programs for their products”, said Pascal King, CEO, Eclipse. “We chose SAS as our technology platform because not only are they a recognised and trusted brand within the pharmaceutical industry but SAS has become the de facto standard for the analysis of clinical trial data.”
“The SAS-based solution ensures that Eclipse can now offer a fully compliant, rapid and flexible offering to their customers in the Phase IV space”, said Paul Flavin, life sciences account manager, SAS Ireland. “For more than 20 years SAS has been used by the pharmaceutical and life science industries for clinical data analysis and reporting, evolving into a recognised industry standard during that period.
“As such it is not surprising that SAS is now used by over 90pc of all pharmaceutical companies, worldwide, within their clinical R&D operations. Likewise, regulatory organisations such as the FDA have also invested in SAS for many years – the most recent agreement signed in 2003 being for US$21m over a 5 year period”, Flavin concluded.
By John Kennedy