So you’re ready to select a Contract Research Organization (CRO) to move your product into clinical trials? You’ve googled CROs, but results turn up everything from large, multinational CROs with an overwhelming number of service options to private niche providers with only very specialized services.
How are you supposed to choose the best one for you?
The selection might seem daunting, but we have compiled our top questions to help you on your way to choosing the best CRO for your project.
First of all...
Does the CRO provide the right services?
A CRO needs to offer all the services you require. The CRO website and marketing materials can be a great place to start, but don’t make assumptions about the activities included in each service. Always discuss this with the CRO so that they understand your needs. You and the CRO are entering into a partnership, and like any good partnership, you need to make sure that you can provide the other party what they need to be successful. A good CRO will be communicative with you, making suggestions and asking pertinent questions about your project. Clarify with them who who will be responsible for each activity. Will it be you, the CRO, or outsourced to a niche provider? When CROs outsource to the right provider, it can improve the quality of the data by taking advantage of the provider’s niche expertise, but outsourcing too many activities can increase the complexity of managing the project and meeting timelines, so be sure to keep this in mind.
If you feel overwhelmed and unsure what exact services you need, consider checking out our clinical and regulatory help desk to chat with one of our experienced team members.
Does the CRO have the right experience to fit your project and fully understand your needs?
Just like interviewing your next job candidate, you want to know what relatable experiences the CRO has with companies/projects similar to yours. Consider: What is your disease state? How big is your company? What kind of product do you have? What kind of help are you looking for, and how often do you need their support? Related experience with companies who have the same needs as yours, whatever they may be, can translate into more efficient, higher quality data and better communication. Take the time to understand both the CRO’s previous clients and the expertise of the CRO’s team. It's likely the CRO’s team has years of industry experience outside the CRO, which may be key to making your project succeed.
How is the CRO’s customer service?
The importance of high-quality customer service is unanimous across nearly every industry. Is the CRO equally dedicated to all its clients and projects? Do bigger projects appear to get more TLC than smaller projects? You want to select a CRO that takes the time to understand your unique needs and provides flexibility to fit those needs instead of expecting you to conform to their typical processes. Will you be competing with Pfizer or Medtronic? Check out the CRO’s clientele. Even if you are a smaller company, your project is your priority. You want your CRO to give it adequate attention. You should never feel that your CRO’s bigger client projects are more “worth their time”. Assess their interactions with you. If you’re engaging with a big CRO and you’re not getting the attention you deserve, try interacting with a smaller CRO, and see if that is a better fit.
Does the CRO provide quality work?
Quality of the data is critical to the overall success of your project and product. It is important to consider the track record of the CRO for delivering quality results. Have you asked for references from past clients? What infrastructure does the CRO have in place? Do their offerings meet the needs of your project? How will the data be organized and shared with your organization? You want to make sure your CRO has an understanding of these topics so that your project can be managed accurately and efficiently, while also meeting all the applicable regulatory requirements. The right CRO can help you think strategically and plan for the hurdles that may occur with your specific project, allowing you to maintain efficiency, and obtain the highest quality data.
What is the cost of services?
Now, let’s talk costs. In product development, cash is king, and sticker shock is no stranger to any of us. Looking at a CRO bid can sometimes make you queasy. Are you going to have to break the bank? Get a few bids from various CROs, and take the cost along with the other qualities discussed above into consideration. Comparing line service costs may be comparing apples and oranges. Talk over the prices with the company to understand everything that is included in each service. Ask them about the payment plan. What are the contracting options? What are the milestones? Make sure you have a good understanding of each proposal before you make a selection. It’s important to keep in mind that selecting the right CRO can provide a team of expertise at a fraction of the cost compared to hiring multiple full-time employees.
We hope these considerations help you to find the right partner for your project. If you have questions or just need help navigating the industry, reach out through our help desk to chat with a specialist or leave a message.
Proxima Clinical Research offers services to help at every stage in biologic, drug, and device development. We love startups and we’d love to help you with your development! No matter who you choose for your CRO needs, good luck on your journey!