It is not a revelation to any of us the current pandemic has had a dramatic impact on our personal lives as well as our work lives. And no exception is the impact on clinical research contracts and budgets.
To summarize a statement made during a June 2020 WCG webinar: Research sites and sponsors need to “recalibrate” how they approach contracts and budgets during COVID-19 – whether for internal negotiation or sponsor site negotiation. That means really taking a look at new ways of conducting trials and how that equates to COVID-19-related expenses and contracting requirements.
What exactly does that include?
- Changes to how research will be conducted;
- Recalculations, amendments, and renegotiations for ongoing research studies;
- Site-mandated COVID-19 screening; and
- Advancements in technology to enable sites to continue research trials during COVID as well as into the future.
In this blog post, we will take a look at how to achieve internal leadership approval – and even sponsor reimbursement – for technology systems, specifically eRegulatory platforms.
Getting internal “buy in”
As it relates to internal budgeting, trying to get an eRegulatory system approved and implemented at the institution can require a “what’s in it for me” approach.
For one research site, in order to get “buy in” from senior leadership and the CEO to purchase an eRegulatory system, the site’s finance and regulatory manager conducted a mini presentation discussing in detail the costs, the ROI, and the timeframe to achieve that ROI. As a result, senior leadership was more than happy to support the budget for a new system, particularly when they learned how much time it would give back to the site coordinator. Often, initially pitching an eRegulatory system can be hard to quantify. But by providing the time tracking data, there is confirmation of the value of such a system, and budget approval is no longer a question.
Addressing sponsor budget negotiations
As with any type of IT system, a new eRegulatory solution can be a large expense for the research site, so seeking sponsor reimbursement often becomes a necessity. Fortunately, sponsors are becoming more receptive to approving the use of eRegulatory systems at sites, even if their approval has to go through several personnel on the study team. Though it may take a little time, patience does “win out”.
A new system can actually help the budget negotiation with sponsors. Many research sites do not typically incorporate the system into the subject amount but instead include it as a separate line item. If it is denied, then most sites go back and add up the rest of the per patient amount – always seeking an increase.
In those few cases where sponsors and CROs have denied the budget add-on for a regulatory system fee, many sites take the stance that if the eRegulatory fee is not going to be paid for, then there will be access to their regulatory systems only during on-site monitor visits. Additionally, these same sites will not send any regulatory documents via email outside of those onsite monitoring visits.
NOTE: Limiting access for where a Sponsor and/or CRO is at on site can get tougher, especially as many sponsors and CROs move to risk-based monitoring.
Here are some insights from research sites on how to address the subject with sponsors:
- Sponsors routinely redline a lump sum for regulatory. That does not mean research sites should stop including regulatory systems in contracts. Continue to identify the cost as a line item; it is a true cost to the site. Sponsors will eventually comprehend the value and the need to include it in the contract. Include the cost throughout the research trial; coordinator time per patient per visit; and general per patient fees.
- Sponsors will always tell you that you are the most expensive site. View it as a compliment — you are able to pay your staff a fair wage and you are able to stay in business to conduct more trials to improve public health and the overall quality of life.
- Work backwards from a billing perspective. Identify how much it costs you to manage regulatory affairs including the resources and tools you use, time and effort, archiving, etc. and distribute that cost throughout the budget. Identify the items as line items but also include the cost throughout the conduct of the trial.
Sponsors are reimbursing the per trial cost to research sites as a separate line item and/or as part of existing startup or archiving fees in a similar manner as for other electronic systems.
The Complion eRegulatory study management solution can completely replace existing long-term archiving costs and also provide significant financial return to the sponsor by enabling remote monitoring access or more efficient on-site monitoring practices.
Contact our team to explore how you can obtain reimbursement for your eRegualtory system while following best practices.
An additional resource: Complion’s Tips on Budget Negotiation.