Information for this article was contributed by Alicia McNeil and Elizabeth Kelchner, Clinical Data Scientists at Rho with significant experience in rescue studies.
No one wants to be here: You went through a lengthy proposal process, endured the bid defense process and thought you selected the best CRO for your study. The contract is signed and the study has started, but things just don’t seem right.
Here are five red flags to watch for if you suspect problems with your CRO, as well as tips for what to do if you decide your study needs to be rescued.
- You loved the team you met at the bid defense meeting, but once your study started you were assigned a completely new (and less experienced) team.
Some new assignments are always a possibility. Maybe one of the team members left the company or a team member was unavailable because a study that they anticipated would be complete ran over. That said, you shouldn’t see substantial turnover on your team, and replacement team members should have similar experience and expertise to those you met at the bid defense.
- Project team members don’t return your calls or respond to email in a timely fashion.
You can’t expect your project team to sit at their desks all day to answer the phone and check their email. After all, they need to be busy working on your project. So what is a reasonable amount of time to wait for a response? Hopefully, they’ve set clear expectations for response times during the kick-off meeting and in the project management plan, but one business day is a typical benchmark for non-urgent communications. There also should be a process and expectations in place to deal with time critical issues.
- You haven’t seen and haven’t been asked to sign off on important study documents.
There are a variety of documents that the CRO should draft during study start-up (project management plan, clinical monitoring plan, data management plan, etc.). You should be given the opportunity to provide input, review, and sign off on these documents as they will set the direction for the execution of the study and ensure expectations are set on all sides.
- You aren’t receiving regular status reports.
Status reports are another topic your project team should have covered at the kick-off meeting and in study documents so that you know what to expect in each area for which the CRO has contracted responsibility. They should be sending you status reports in a consistent format on a regular schedule. The reports should include enough detail that you can track the progress of important activities and gauge any significant risks to the study.
- There are signs data isn’t being collected or managed properly.
In a study that is running smoothly, you should expect to see the following in terms of data collection and management:
- Data is being collected in a system designed to handle clinical trial data. If data is being collected in spreadsheets or another unorthodox manner, this is a very significant problem. This may seem obvious, but more than once we’ve rescued studies where data was being collected into Excel spreadsheets.
- You are given the opportunity to participate in User Acceptance Testing (UAT) if your study is using EDC. This is a good way to familiarize yourself with the specifics of how data is collected and what sites will experience, and it demonstrates transparency on the part of the CRO.
- Queries are being sent and closed on a regular basis. As soon as sites start collecting data, you should be getting updates about queries sent and closed.
Sometimes, despite your best efforts to correct course with your CRO, you may decide that you need to change CROs mid-stream. Here are some tips for interacting with your existing CRO before and during the transition as well as tips for selecting a CRO to rescue your study:
Tips for working with the incumbent CRO:
- Keep copies of all documentation (study plans, annotated CRF, build specifications, decision logs, etc.) in case you need to transition to another CRO. Don’t rely on the incumbent CRO to do this. The more historical information available to the new CRO, the better.
- Get regular data transfers.
- Request and implement a communication plan. Know how to escalate issues if needed.
- Have regular meetings with all team members to keep everyone on the same page. If possible, meetings that include both members of the incumbent CRO team and the rescue team can make the transition much smoother.
- Avoid burning bridges with the incumbent CRO early in the process.
- Negotiate the financial side of transitions carefully so that the incumbent CRO can work as necessary to complete tasks where practical given timeline constrains as opposed to relying on the new CRO to complete all tasks. This also allows appropriate communication between the incumbent and the new CRO.
Tips for Selecting a CRO for the Rescue
- They should have a thoroughly documented rescue process or rescue project plan template.
- They’ve successfully implemented rescues between the applicable platforms (i.e., EDC to EDC, paper to EDC, EDC to paper).
- They understand the need to minimize and manage process change for clinical trial sites.