The European Commission has recently announced proposals to address increasing administrative costs and a decline in the number of cross-border clinical trials conducted in the European Union.
The proposed legislation, expected to be enacted by 2016, aims to speed up authorization and reporting procedures while ensuring patient safety and data quality.
Greenphire has affirmed its support of the new regulation and its focus on alleviating the administrative burden of trials taking place across multiple geographies.
Greenphire is committed to reducing administration associated with clinical payment processes through innovative platforms such as its eClinicalGPS technology.
The European Commission reports that the number of clinical trials carried out in the European Union between 2007 and 2011 has dropped by 25 per cent, with applications down from over 5,000 in 2007 to 3,800 in 2011, while administrative costs have doubled.
This trend has been attributed to the 2001 Clinical Trials Directive, which imposed tighter controls on monitoring and reporting drug trials.
Currently, companies or researchers seeking to conduct clinical trials in more than one EU country must submit separate applications and reports in each country.
Under the proposed new system, applicants will only have to submit this information once. The new regulation streamlines this process in order to make pan-Europe an attractive place to conduct trials.
According to John Dalli, European Commissioner for Health and Consumer Policy, the new legislation could save over 800 million euros per year in regulatory costs.
John Blakeley, Chief Commercial Officer of Greenphire, voiced his support of the proposed regulation, saying: “Greenphire welcomes new measures to facilitate the implementation of cross-border clinical trials and ease administrative burdens. In addition to achieving its main goal, this legislation will also benefit research in areas such as rare diseases where there may be only a few subjects in each country, and which may otherwise face bureaucratic obstacles."
Blakeley continued, "Greenphire currently helps trial sponsors to implement studies across multiple geographies through our global web-based clinical payment management platform, the eClinicalGPS. In contrast to more expensive and time consuming manual paper-based payment processes currently used in clinical research, Greenphire's automated electronic system enables sponsors and CROs to automatically distribute payments in over 200 currencies to all investigators, sites and vendors globally.”