Parexel launches software for post-approval trials
pharmafile | April 12, 2010 | News story | Research and Development |Â Â CRO, ParexelÂ
Contract research organisation Parexel has launched a new web-based technology platform for late phase clinical research that it says makes large-scale trials, such as post-approval studies, more cost-effective and efficient.
“Post-approval studies have continued to expand measurably in number, size, and complexity in recent years,” said Parexel’s Carol Collins, who heads the CRO’s Peri-Approval Clinical Excellence (PACE) division.
“As a result, biopharmaceutical companies require much greater efficiency in managing the high volume throughput of data while controlling the costs related to these programmes.”
One driver for the growth in the post-marketing trials market is an increasing regulatory demand for long-term safety and efficacy data.
The FDA – stung by criticism that is was not ensuring that drugmakers carry out post-marketing studies agreed to as a condition of product approvals – unveiled a five-year plan in 2008 to increase enforcement as part of the Prescription Drug User Fee Act (PDUFA) IV programme. That was accompanied by a major recruitment drive to boost the number of staff working in this area.
Companies are also starting to realise the value of post-marketing data from a health economics perspective, in light of the increasing need to demonstrate cost-effectiveness to satisfy health technology assessment (HTA) agencies such as the UK’s National Institute for Clinical Excellence (NICE)
Meanwhile, post-marketing studies are increasingly being used by the pharmaceutical industry to identify important information that is not readily available from pre-approval studies, such as the overall cost of therapy and whether it reduces the time a patient in hospital or affects the need for concomitant therapies or diagnostics.
These studies can also look for safety signals, improve understanding of disease characteristics and help guide the development of new therapies, and uncover unexpected relationships and interactions with a drug.
Parexel says it has responded to this shift with the new web-based software platform, which was designed by its Perceptive Informatics eClinical division in close collaboration with Collins’ PACE group.
The platform boasts an intuitive interface, automated cues for late phase site requirements to enable improved compliance, enhanced reporting capabilities and centralised access to data including site, patient, and clinical supply information, according to the CRO, which maintains that it can be used to generate better quality data at a lower cost per patient.
The system works in conjunction with other eClinical tools such as clinical trial management systems (CTMS), electronic data capture (EDC) and electronic patient reported outcomes (ePRO), said Parexel.
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