Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can improve efficiency and increase productivity, thus allowing your organization to focus on its core strengths.
However, the reality is that selecting a CRO is a very subjective process. Quality is variable and can be influenced by many factors. Consequently, it is essential that you follow a disciplined approach that is performed with the oversight and management of an independent consulting firm such as The Weinberg Group.
Here are a few important questions that must be asked of the CRO’s representative during the vetting process.
1. What Services Does the CRO Provide?
You want to make sure that the CRO provides the services that you intend to outsource. This is where reading the CRO’s marketing materials is not enough. It’s important to have a discussion with them during which you can confirm that they understand your needs and can provide the required services.
It’s also a good idea to gain an understanding of whether the CRO’s services will be provided by CRO employees, by subsidiaries, or through alliances with niche service providers. There are tradeoffs depending on the way the CRO provides its services. Having all the services under one roof may make project management easier. However, niche service providers can outperform a large CRO in their area of expertise.
Finally, ask the provider for suggestions regarding services that might contribute to the efficient and successful completion of your project. Their answers will help you fully understand their capabilities and their expected commitment to your project.
2. What Related Experience Does the CRO Have?
You need to know what related experience the CRO has. In the human resources world, it’s unlikely that you would hire someone with little to no experience with the job they are expected to perform. Likewise, other factors aside, a CRO that doesn’t have experience related to your project may not be your best choice.
Another characteristic to consider is whether the CRO has experience working with a company like yours. Whether your company is large or small, it has its own culture and its own set of priorities. If the CRO has worked with companies like yours, you can expect a smoother relationship.
3. How Financially Stable is the CRO?
The CRO business involves significant risks. It is important that you feel comfortable that the CRO is strong enough financially to withstand any downturns the project may face. So, ask the CRO how long they have been in business. Is their portfolio of clients sufficiently diversified to mitigate risks? What do they do to facilitate sound cashflow management?
4. How Does the CRO Deliver its Services?
You want to know as much as possible about how the CRO delivers its services. This knowledge includes an evaluation of how their processes will integrate with yours.
While it is key to establish a single point of contact, it is important to meet with the key person(s) who would be working on your project. Ask them who is responsible for managing the project schedule and budget. Who supervises the project team? And, who is ultimately responsible for your project?
5. What is the CRO’s Client Satisfaction Record?
Client satisfaction is an important data point for projecting the CRO’s performance on your project. Be sure to ask for multiple client references to get as much feedback as you can about their experience working with the CRO you are evaluating.
6. How Solid is the CRO’s Infrastructure?
Much like the importance of financial stability, it is crucial that the CRO’s infrastructure can support your project’s requirements. Check to see whether the CRO has adequate facilities and staff to handle your project’s requirements. Ask whether the clinical data is maintained in accordance with 21 CFR Part 11. Also ask how they manage essential study documentation and what mechanism they provide to facilitate sponsor review of clinical study data.
7. Does the CRO Employ Satisfactory Quality Assurance?
Always ask questions about the CRO’s quality assurance practices. Quality assurance is key to good clinical research practices, and FDA decisions regarding product safety and efficacy are based on the demonstration of study integrity. Ask what methods the CRO uses to confirm the quality of their work. Also ask whether the CRO has been audited by the FDA. If so, what was the outcome?
Let The Weinberg Group Help You Select Your CRO
There are many considerations that you must make when selecting a CRO. Depending on your specific needs and the nature of your program, some qualities may be more important than others. Even so, it helps to have some guidelines for your evaluation and selection. You will also benefit greatly from the oversight and management that The Weinberg Group can provide.
If you have already selected a CRO, it’s not too late to make sure that you are getting the best services possible. The Weinberg Group is here to audit your CRO to determine whether they meet the standards discussed above, as well as additional standards that we recommend.
Ultimately, the CRO you choose will have a significant impact on the success or failure of your program. Choose wisely.