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Tag: realtime-ctms

25 Nov 2019

Ask the Experts: Getting sponsors to cover your site-based electronic solutions

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

If your site is interested in learning more about RealTime and our software solutions, give us a call at (210) 852-4319 or fill out a CONTACT FORM.

01 Oct 2019

Q&A with Rick Greenfield: RealTime-Enterprise

Large-scale research data can seem overwhelming in a data-driven industry. While managing a multi-site or extensive site network, centralizing processes and taking advantage of multiple resources across the network is the goal, but few systems on the market can truly bring this level of efficiency to a site network.  Aggregating data and providing valuable network-wide metrics for enterprise-level decision making and forecasting is another goal that is often difficult to make a reality. We had the opportunity to speak with Rick Greenfield, CEO of RealTime Software Solutions on the RealTime-CTMS Enterprise system and how it can help solve the above challenges and more.

Interviewer: What is RealTime-Enterprise?

Rick: RealTime-CTMS has enterprise-level platforms that can scale to meet the demands of the largest and geographically diverse site networks, hospital systems, and universities. Enterprise systems connect CTMS to allow for a perfect combination of separation. In regards to local resources and patient databases, these systems provide enterprise-level managers and officers with visibility across the network and aggregate data to track production, profitability, business development, and more.  Further, RealTime’s Enterprise systems allow for real centralization of processes such as finance and accounting, eREGULATORY processes, patient recruitment, and even eSOURCE creation and data collection.

Interviewer: Who can benefit from RealTime-Enterprise?

Rick: RealTime’s Enterprise systems can be found today in medium-sized multi-site networks with geographical diversity as well as extensive international site networks spanning multiple countries.  Because we have servers strategically positioned around the globe, we can also meet the strenuous and varying data privacy laws of countries such as Canada, Australia, New Zealand, the entire EU.

International Data Compliant Seal

Interviewer: How does RealTime-Enterprise differ from RealTime-CTMS?

Rick: RealTime-Enterprise leverages all of the tools of the RealTime-CTMS and SOMS products so that each site within the network can leverage the most powerful grouping of products on the market.  The RealTime-Enterprise platform connects sites for centralization and aggregation of systems and data.  In short, RealTime-Enterprise brings the best of the best CTMS solutions together into an unparalleled platform for network-wide management.

Large-scale data needs large-scale systems. RealTime-Enterprise brings systems and data together, like no other.  Find out how your medium to large-scale organization can benefit from RealTime-Enterprise systems to lead the shift to centralization and efficiency in the site network landscape!

Interested in a demo? Give us a call at 210-852-4310 or CLICK HERE to fill out a contact form!