Site-based clinical trial software systems such as RealTime-eDOCS and eSOURCE are becoming more commonplace and essential than ever before. These solutions are part of a fast-growing market of site-based systems in the research industry that is reshaping research processes. One common topic of concern of the sites is the cost of these systems and the potential to have those costs covered within their clinical trial agreements and study budgets with the sponsors. The efficiencies that these systems bring to sites substantially, if not entirely, offset the costs. In addition, there are benefits for sponsors and CROs, which include remote monitoring, real-time access to study data and documents, complete oversight of Investigator and staff performance, and more.
This article will provide some justifications and best practices that sites can leverage to request and receive compensation from sponsors, which will, at the very least, help to cover some of the costs associated with these advanced systems.
In the course of working with hundreds of sites that are currently leveraging these robust systems, the RealTime team has observed practices used by sites in approaching sponsors to help cover the cost of their site-based electronic systems. Here is what we found:
- Sites that are confident in their electronic systems and processes tend to be better negotiators. They understand the value that the system brings to, not only to their operations but the sponsors and CROs as well. The shift to these systems is no longer a question of “if” the industry will adopt site-based electronic paperless systems, but “when” the transition will be realized in full.
- One way to quickly consider the offset of eRegulatory systems is to consider the fact that the typical Archival Fees that sites receive to archive and store records will no longer be needed to cover the cost of storage. For systems like RealTime-eDOCS, there are no annual storage fees. Further, the archival process can be substantially reduced to a simple review and validation that all documents are present in the regulatory system for long-term holding.
- For eSOURCE, sites are encouraged to increase the per-visit revenue by at least $10 per visit. By doing so, this will cover the cost of CTMS and eSOURCE for that study, in full. Many sites add a line into their study budgets for QC/Data Entry with a rate of at least $10 per visit to cover the cost of data review for accuracy and data entry into eSOURCE and EDC. Some sites are consistently successful in receiving a rate of $25 or more for this fee.
- Some sites add the cost of their electronic systems to their General Overhead Fee. A 1 or 2% increase in overhead across all studies will easily pay for your eSOURCE system.
In one case, a site that grouped everything into a “Systems Fee” was able to get the costs of their electronic systems completely covered by the sponsor.
One thing to remember, having consistent processes is paramount to quality and efficiency so it only makes sense to go “all in” with your paperless systems. Even if the sponsor only covers partial or none of the costs on a particular study, the efficiencies that these systems bring to the site as a whole are still worth it. Utilizing site-based paperless systems has shown to increase productivity, efficiency, and collaboration on every level.
In other words, the improvements in efficiencies and increased revenue opportunities make paperless systems worth the cost. You will be able to do more for less, so the cost is well worth the benefits. But, there is no question that sponsors and CROs should share in the cost as they too benefit greatly from these systems. Real-time data, remote monitoring, complete transparency of investigator oversite and site performance, are all enormous benefits that are worth far more than the budgetary increases that sponsors may see from sites.