Using eSource, as opposed to paper source, in a clinical trial certainly has its advantages. From increasing the data quality, to differentiating the clinical research site in site selection, eSource is poised to break out in the clinical research industry. However, fully adopting eSource requires investments, both in the time it takes to implement this new technology, and the monetary cost associated with the software.
Here at CRIO we can give you plenty of examples demonstrating why eSource is worth these costs,
(like eliminating stickies at your site or the fact that industry is moving towards eSource or being able to mitigate deviations by 50% or reduce the money your site is currently leaving on the table or gain 32% more time in your busy day ? You get the idea. Don't believe us still? Let us show you!)
but we also understand the blocks that must be overcome when implementing new software, especially those relating to a site's budget. We put out a call out to our clients asking them how they were able to get eSource reimbursed into their research budget. It's not a slam dunk, but here are some best practices for adding eSource into your clinical trial budget.
1. Position eSource as a pass-through in your clinical trial budget
- If we're designing your eSource for you ($1000/study for source/budget), position it as a pass-through from the vendor for "eSource configuration" in your clinical trial budget.
- If you combine this eSource design with our archiving fee, consider asking for $1500 as a pass-through from the vendor for "eSource configuration and hosting" in your clinical trial budget.
- If you are asking for a line item for just our archiving fee in your clinical trial budget, and you want to make it incremental to record retention, consider positioning it as an "online hosting fee for remote access."
Note: CRIO will furnish appropriate documentation for any pass-throughs you are attempting to add into your clinical trial budget negotiations!
2. Articulate the benefits of eSource to the sponsor
- Stress data quality and the ability to perform remote monitoring. For instance, if you are asking to add a "hosting" fee to your clinical trial budget, stress that post-closing, you'll be able to provide the sponsor with on-demand online access to archived source, instead of their having to haggle with you to retrieve paper source from a storage locker.
3. Position eSource fees as CRA premium access
- Some clinical trial sites pass through our per-visit fee by adding in a "24/7 remote access fee" line item to their clinical trial budget. This line item entitles the CRA to access the source at any time-- not just during their on-site visits.
4. If all else fails ... have you tried raising some of the procedure costs in your clinical trial budget?
- Many sites simply add $5 here and there onto their procedures, or $500 for this start-up expenditure, etc. A lot of sponsors have authorized limit levels by category, so it could be a matter of finding the appropriate categories.
- Remember that CRIO's integrated eSource-Finance offering makes it really easy to capture contingent procedures, so you should take full advantage of this by ensuring your clinical trial budgets capture all the optional procedures!
Ready to take a shot? Here is advice from a few of our clients on adding eSource into your clinical trial budget:
Anna Krauss is a Project Manager at Clinical Research IO. She has experience in the health field through her work as a Research Assistant with the MaineGeneral Hospital system, Hospital General de Agudos Bernardino Rivadavia in Argentina, and through her experiences working as an EMT.