Is your current data management provider struggling? Perhaps they are under resourced, have antiquated SOPs, use cumbersome systems, or are simply not a good fit for your team and culture. All these items contribute to poor quality either overtly or more subtly by revealing themselves at, unfortunately, the wrong time.
Too often, sponsors fear changing providers especially in data management due to project disruption and cost concerns. This paper addresses these concerns and provides high-level guidance enabling sponsors to take charge of data quality and ultimately to not accept poor performance from their current vendor.
From a project disruption perspective, it is true that changing data management providers mid-study can cause study disruption. That disruption, though, can be lessened if the following approach is followed:
- Data Management Transition
During the assessment phase, the new provider works with the sponsor to assess the current data management situation which addresses the elements, including:
- procedures currently being followed,
- resourcing allocations of the provider,
- status of project,
- assessment of what has been completed,
- inventory of documents produced,
- communication plans,
- vendor personality and transition risk.
The outcome of this assessment is a Project Transition Plan (PTP) with actions and contingencies outlining how the transition will occur.
Harbor Clinical works with the sponsor to implement the transition plan and supports the sponsor with the appropriate messaging to the current vendor. Harbor Clinical will take over immediately in the event a less than professional reaction is provided by the current provider. Steps are taken to prepare for this scenario. This is a key step in that, the new provider must have the team available and trained to take over at the time of notification to the current provider. Harbor Clinical assembles an available, functionally aligned, team early in the process with an identified Lead Data Manager (LDM) and overall Transition Manager.
After the initial messaging to the vendor, the new provider must be confident and function as if they have been performing the study all along. This confidence will be required when working with vendors, sites, and others on the study team. The new provider must appreciate that they were chosen to improve the situation within data management and must demonstrate their ability to do so.
Once the new provider is functioning independently and has assumed the tasks associated with the project, they must review the work that was done to ensure all services were transitioned and determine if any items are outstanding. A review of the transition plan is key at this point to confirm all items have been addressed. Further the transition plan should be updated if additional duties not initially considered have been done to complete the documentation process of the transition.
From a cost perspective, rescue studies do have additional costs such as creating and implementing the transition plan mentioned above, training new staff members, and potential retraining to be provided by team members and other vendors to the new team. These costs, however, need to be reviewed in combination with the quality related challenges with the existing provider. Poor quality has costs that manifest themselves in the form of rework or under-scoping of the project. Both can lead to expensive change orders which are likely not factored into the study budget. Given that, financial justifications regarding the additional up-front cost of the transition spend can be assembled on a case by case basis based on these two future cost drivers. Our experience at Harbor Clinical has shown that overall costs tend to stay relatively neutral with possible slight increases up front while the quality delivered by the Harbor Clinical team far exceeds both sponsor expectations and the delivery of the incumbent provider.
Finally, the mental and time-consuming cost of working with the wrong data management provider is not as easy to quantify but does have significant impacts to the organization as well. If the vendor is not the right fit for the organization turnover within the sponsor organization can occur which has its own set of project disruption issues and can impact the important sponsor and site relationship.
Given the above, it’s important to consider the overall impact of the wrong data management vendor and understand that with proper planning a vendor transition can have limited project disruption and be cost neutral or effective while providing peace of mind that study data are being properly managed.
Harbor Clinical leadership provides our sponsors with a project transition plan based on years of proven experience combined multiple organizations. Submit your contact information or email us at firstname.lastname@example.org if you’d like additional details or would like to discuss your unique scenario.