Clinical trials are a costly business. In 2013 alone, the biopharmaceutical industry spent nearly $10 billion on clinical trials. Operational failures in clinical trials can increase those costs and create delays in time to market. So when you pick a CRO, you want to ensure that at best they are mitigating operational risks, and at worse aren’t introducing new ones. Stability can play a significant role in this.
When looking to outsource to a CRO, there are several aspects of corporate stability that should be assessed:
- How long has the CRO been in business? The newer the company, the more likely that they don’t have the overall experience you may need. Additionally, they have a shorter history with their clients, so it will be difficult to assess past customer satisfaction.
- Are they financially stable? A company that isn’t profitable, has a lot of outside debt, or is under strain from shareholders or investors may be making short-term business decisions that aren’t in the best interests of your study or program. Worse yet, they could go out of business in the middle of your clinical study or run into cash flow issues that impact the success of your clinical trial.
- Have they recently been involved in M&A activity, have they gone public, or are there plans to do so? This type of activity typically comes with significant organizational impacts that can bleed over into day-to-day activities. From changing SOPs mid-study to project team turnover, it rarely has a positive impact in the short-term for existing clients.
Consider incorporating questions about these topics into a request for information (RFI) or as part of the request for proposal (RFP) process. These are valid questions that CROs are used to addressing, so be wary of companies that are reluctant to do so.
A good measure of how well you will be treated once the contract is signed is the satisfaction of existing and former clients. You should look for a CRO that has long-standing relationships with many of their clients. You’ll often see CROs that have slides listing the logos of their clients or with testimonial quotes from clients. That’s all well and good, but you need to check for yourself. Ask for references whose work is of similar scope and for similar services as those you are planning to outsource. Contact references directly rather than relying on the CRO to act as an intermediary.
Employee turnover rates across the CRO industry are incredibly high. In 2015, CRO turnover was 25% despite the fact that team stability is a key factor in meeting sponsor expectations and in doing high quality clinical research. Make sure you ask both about turnover and about the tenure of your assigned team. A team with multiple members that have recently joined the company should be a red flag. In addition to company turnover, find out what you can about project team stability. Keeping a team together over the course of a study means less re-training, fewer mistakes, and less re-work. There is a learning curve with each new sponsor and product. If you are considering outsourcing multiple trials particularly within the same program, ask if the same team members can be assigned to future studies.
Learn more about selecting a CRO by checking out the outsourcing tips on our blog.