CRO Red Flags: Signs Your Study is Being Put at Risk & Considerations for Selecting a Rescue Partner

Failed enrollment – especially when combined with obstacles like poor quality, poor communication, severe bottlenecks, or lost access to resources – sometimes necessitate a rescue to “save” a trial from an underperforming CRO.

Study rescues are a delicate and complex process.

When possible, we advise bringing in a clinical trial consultant as soon as you develop study concerns. An unbiased third party can accurately advise you on what kind of rescue you may need and walk with you through the rescue process.

Each scenario is different, and an experienced consultant focused on the “big picture” can help determine the most cost-effective—and least stress-inducing—fix. Options for study rescues may include:

• Can your study get back on track with simple oversight?
• Should a companion CRO take on part of your current CROs workload?
• Do you need a full study takeover?

 Seven Signs Your CRO is Putting your Study at Risk

1. You’ve experienced a team bait-and-switch: You were initially impressed by the expert team you met at a bid defense meeting…but once your study started, you were assigned a totally new, less experienced group to work with.
   
2. You’re frustrated by a lack of timely communication: The team members you’re supposed to be working with aren’t responding to your emails or returning calls in a timely manner.
3. Your CRO can’t explain how they’re going to achieve their aggressive timelines: It’s a red flag when you’re being presented with crazy-impressive timelines that have no information or experience to back them up. Over-optimism partnered with under-planning is never a good sign.
4. You notice a lack of coordination across vendors: There are many people involved in the clinical research process, and these parties need to be able to work cohesively under the guidance of your CRO.
5. You haven’t signed off on start-up documents yet, and you’re getting worried: Your CRO didn’t create a plan for communication at kickoff. Along the same line, you should have received—and signed off on—important documents like study start up plans such as the clinical monitoring plan in a timely manner, as well.
6. Your CRO doesn’t seem to be using any of the right tools or technology: For example, your CRO is collecting data in Excel spreadsheets instead of a system designed to handle clinical trial data.
7. Your CRO is not cleaning data in a timely manner: Your data doesn’t seem like a priority for your CRO.

Four Considerations for Selecting a Clinical Trial Rescue CRO

1. Do they have prior rescue experience? Rescues can be challenging for any CRO, especially if communication with the incumbent CRO is poor and major issues are not readily apparent.
2. Has the rescue CRO successfully supported studies similar to yours in the past (e.g., similar indication; virtual study experience, if applicable; experience overcoming the current challenges you are facing)?
3. Does their rescue plan support minimal disruption to the site?
4. Do they have contingency plans prepared?

 Consultative, client-focused CROs will emphasize the importance of keeping rescues cost-effective for sponsors, focusing in on key strategies to get studies back on track swiftly and transparently.

Don’t wait until it’s too late: if you have concerns about your ongoing clinical trial, contact a member of the PharPoint team to set up an introductory meeting. PharPoint is proud to be a trusted clinical trial rescue partner and has done a variety of service rescues.