The initial shock of clinical trial inefficiency
We’ve all made purchases that we regret – but what happens if that purchase was supposed to help your organization manage your clinical trials effectively and efficiently? If you are beginning to get that sinking feeling that you signed with the wrong CTMS, you are not alone. This happens more frequently as aggressively marketed solutions generate confusion during these stressful times.
Everything looked like it would be great – the demo seemed to showcase everything needed to optimize your study workflow process. But then during implementation, something in the data migration delays study startup or it comes to light later that there is no good way to manage recruitment or finances. These aren’t simple interface issues that can be resolved in a future release with your feedback, but true work-stopping issues due to missing functionality or poorly designed data, task, and finance handling capabilities — including trouble across complex networks or a variety of studies.
Even worse, you may have to pay excessive fees to get out of the contract with the incompatible solution, having no other choice if you want to avoid further delays and lost revenue. Even an experienced clinical trial team recently had this to say after a botched transition from a previous system…
“… all smoke and mirrors… I feel like we were conned.”
With so many CTMS and eClinical options available, and the pressure to get started right away increasing every day, it is easy to fall for a demo that you later realize was simply covering a lack of needed functionalities.
What to do now? Evaluating current standings of your research
First, you’ll need to determine how far along you are in your study and what risk the underperforming CTMS poses to the success and continuity of your research. Are you still in deployment and configuration, or is that long past and you are simply running into show-stopping inadequacies left and right?
If you are lucky enough to catch data migration issues before going live, you may still be able to stop the presses before that happens. Unfortunately, it may not be that simple depending on your organization. Could there be champions of the failing system or decision makers that might be upset that you want to look for another CTMS? Most importantly, do you and any other influencers feel that you have enough information about the issues to justify halting the process?
What happens if your team was able to get through the CTMS deployment without having any issues, but now it’s clear that your new CTMS lacks key functionality that is critical to conducting a smooth clinical trial?
Documenting the nature and study impact of the issues encountered is vital. First, build a list of criteria you can use to quickly evaluate an alternative CTMS that can reverse the situation; it would be beneficial to your case to have a solution ready to be suggested if your organization is ready to make a change. Second, documenting the short- and long-term impacts on the study will allow you to better justify the need to halt and secure the more capable CTMS to avoid further study delays.
You will also be better positioned with information to potentially get out of the contract, since it may take some negotiating with stakeholders to get some movement. Even with fees, it is important to stress that taking the steps necessary to negotiate the end of your contract will be critical to getting your studies back on track. This is why documenting the exact nature, damage to workflow, and impact on the study of the existing CTMS issues is critical to move forward.
Even if your organization acquired a CTMS and/or eClinical solutions for the first time, there are always examples of dashed expectations. These include segmented build processes, the inability to conduct basic CTMS integrated screen-fail processes with an eSource solution, cumbersome or totally missing finance management, lack of control over invoicing or budget amendments, hidden limitations on number of PI’s or vendors, and even lacking oversight of key completion or status information. One comment from an exasperated finance user of such a system said “…a total joke… it duplicates or triplicates numbers”, which could have risked billing fraud accusations if it had not been caught in time. One of these systems even paid stipends multiple times and could not pull financial reports.
Finally, don’t forget another common issue, inadequate or downright antagonistic support. Good customer service is critical for both small and large organizations, though it easy to overlook the reputation of a vendor in this regard, especially when presented with a nice-looking application demonstrated by skilled presenters. It can become especially aggravating when confronted by a bad attitude from a support person on the other side. There is of course no excuse for such behavior, but it has been known to happen in some of the cases mentioned above.
Fixing the situation! Moving to a CTMS that performs.
In the end, what do you really want? A real solution grounded in years of industry expertise, or a nice-looking shell with broken capabilities and a contract you will lose time and money trying to get out of later? What if the more capable system is also part of a full eClinical suite with remote monitoring enabled eSource, paperless eBinders, remote eConsent and secure video conferencing? How about free training and attentive support to help you feel the high satisfaction of long-time users sooner?
You get the idea. It does not matter how professional the user interface may be, if it doesn’t have the capabilities and quality of services you need, what’s the point? With better and more robust CTMS functionality and a full suite of eSource, eRegulatory and eConsent solutions, a more comprehensive system can seem more complex at first. However, the comprehensive nature of an industry proven CTMS and eClinical suite will truly make a positive difference. There is no need to endure a system that is simply getting in the way of accomplishing your goals.
If you need a quick analysis to verify if our comprehensive solution can save the day, please click here to setup a meeting with one of our experts.