Aimed at trial sponsors, investigative sites and contract research organisations (CROs), the service includes regulatory document collection and management, alongside global investigator budget and contract management, and is specifically designed to minimise the financial risks inherent in the trial process.
Greg Seminack, CFS president and managing partner, said he believed the new service would help expedite all aspects of the trial process by allowing companies to better focus on the trial itself.
“With complicated regulatory documentation, tight timelines, and the newly passed Sunshine Act [US legislation which demands all payments and gifts to physicians and teaching hospitals be disclosed], proper business and financial management of clinical trials is more important than ever,” Seminack explained.
“Partnering with CFS not only allows sponsor organisations to manage these requirements efficiently and cost-effectively, but significantly improves investigator relationships and ultimately helps get drugs to market faster.”
The Audubon, Pennsylvania-based company said it had assembled an experienced team dedicated to managing the complex tasks required to activate investigator sites, such as ensuring a site is ‘enrolment ready’ when the enrolment phase of a trial begins.
In addition, through its Site Activation Service CFS offers to pre-populate regulatory and financial disclosure documents, ensure the accuracy of site and investigator information, ensure compliance with various FDA regulations regarding payment data, and support complex contract negotiations through its legal team.
Founded in 2001, Clinical Financial Services markets itself as the only company in the clinical trials industry dedicated solely to providing business and financial management services for clinical trials.
The company claims to have worked alongside a host of clinical trial sponsors, including 6 of the world’s top 20 biopharma companies, in helping them “focus on their core competencies and reduce cycle times and costs.”