5 Red Flags Your CRO Is Putting Your Clinical Trial At Risk

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. 

1. 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.

2. 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.