Billing Compliance Considerations in Times of Uncertainty

Sponsor billing and regulatory compliance often top the list of things that keep clinical research trial leaders up at night. In times of uncertainty, the factors that make these trial elements challenging only increase. However, there are ways to tackle financial and compliance issues during uncertain times that can make a trial site come out stronger and more profitable for the future. Some key things to consider:

Sponsor Billing

  • Consider if your site is able to easily track and visualize complicated clinical trial financial activity to a level of granularity needed for payors. At a time when both current and future trials could be in jeopardy of moving forward, demonstrating your value to sponsors is more important than ever. Sponsors should be able to easily understand how a site approaches enrollment, tracks and organizes data, and provides reliable clinical trial results. Ensuring efficacy reports are aligned with billing statements keeps providers focused on why they are getting value from a site partnership.
  • Determine if there are opportunities to recover unbilled payments by using a CTMS to identify possible disparities between charges that were allowed and those that were actually billed to sponsors. Find out how one clinical trial research organization recovered $100K in unbilled payments by using CC CTMS. 
  • Consider what investments are beneficial to sponsors and include those costs in RFP submissions. With direct sponsor benefits, adding eRegulatory functionality is a prime candidate for sponsor funding as ROI can be shown in terms of risk reduction, expanded study capacity, and improved regulatory visit efficiency. 
  • Transition from passive sponsor invoicing to a more proactive model by using a CTMS to connect payable elements of each trial to patient visit updates made by site staff. By connecting financial tracking to trial activity, the system can identify billable work in real time and proactively billed to sponsors. This alignment can enable more detailed invoicing, shorten payment times, and improve revenue cycle metrics.  

Regulatory Compliance

  • The necessary move to remote trial management has affected virtually every clinical research site. Consider how an eSource solution can ensure compliance with 21 CRF 11 regulations by both empowering effective capture data  and enabling access to compliant workflows from any location.
  • CRA site visits have also been affected amidst the backdrop of working in a virtual environment. Consider how sites can best position themselves as a helpful partner to both sponsors and government audits. Early communication with monitoring organizations to alert them to your CTMS and eRegulatory system configurations will allow their CRA staff to better prepare for visits. Further, deploying a digital system can enable finding and distributing the regulatory data that compliance teams require.
  • Determine how effective your site is at tracking compliance at the patient, site, and multi-site level. For example, protocol adherence is a measurable element of any trial; the more patients who are following protocols means a more comprehensive and successful trial. Leverage a CTMS to track out-of-window visit requirements, site-to-site protocol adherence rates, staff time allocation, and other data that can help uncover best practices to leverage across your network of care. Learn how CC CTMS enabled protocol adherence and staff utilization improvement at one clinical trial site. 

Now is an ideal time for clinical research trial sites to invest in tools that enable successful and profitable trials both now and in the future.  Request a demo of our CTMS and eClinical solutions to get started today

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