For many companies, selecting a CRO can be a stressful task as it is important to find one that could be your partner throughout the clinical trial process. And given that the time from the start of human clinical testing until a drug is actually approved by regulatory authorities can be anywhere from 10 to 18 years, you could be in for a long-term relationship with a CRO.
I’ve been asked by many of my clients what steps should be taken and what questions should be asked as they go through the process of evaluating CROs for their company. When starting your search, one of the first questions to ask a candidate firm is if they can provide all the services you need. Know up front if their services include study design, a medical director to participate in defining inclusion/exclusion criteria and a biostatistician to determine how to power the study. You also want to know if they can run bioassay testing of samples and if they can develop and validate the bioassay method.
You’ll also want to find out if the CRO will outsource any of the work and, if so, what type and to whom. It’s also a good idea to know if the outsourced company has a relationship with the CRO or is a third party. If they do outsource, how long have they worked with the other company and do they have a quality agreement in place?
Next, you’ll want to know a CRO’s qualifications before making a decision. To start, ask them if they have completed other Phase 1 studies similar to the one you will be doing and, if so, ask for some examples. Other key information to ask is how many similar trials they have completed, in what therapeutic areas and if they have experience in trials with similar molecules to gain a sense of their expertise.
While it may seem like a sensitive subject, you should ask what challenges the CRO encountered. To me, how they handled the problem is more important than the problem itself. How they answer this question is a good way to assess if they are straightforward and candid. Establishing trust with a CRO is crucial.
Other questions: Will you be assigned a dedicated team for the duration of the project? Will they share the CVs of team members?
Is their style nimble or bureaucratic? You want to find out how decisions are made and who makes them? Also, are they made independently or in tandem with the client?
Establish how two-way communication will occur so that your expectations and theirs are aligned. If not, you may run into problems. And if you do, will you have to navigate multiple levels of management?
If you are a small company, you want to know if they can meet your needs as many CROs are large company-focused. Other key questions: What is their on-time record (and not just when a study begins and ends, but milestones)? Were they met or not? And if not, why?
Other questions: Will they give you a total package price? Is there a guarantee that, if they are at fault and study data are compromised, you will know about it? Will they bear responsibility for it?
You’ll also want to speak with a client as a reference. I suggest maybe two or three. And if they say no, ask them why. Speaking with a client will give you a feel for how it has been working with the company from someone in similar shoes as yours.
In this area, right off the bat, you want to know when the CRO had their most recent FDA 483 inspection. It should be within the last three years. The more recent, the better. If they have had more than one in the last three years, that could be an issue. Look at any of their 483s. How many issues were flagged and how serious are they? Are they recurring?
You also want to look at the compliance history of any third parties utilized. Is there a quality agreement in place? Quality and compliance are your top concerns all along the way. Also, look at the CRO’s quality management system. And, if necessary, secure a qualified auditor to conduct a GCP compliance audit.
Here are some other questions you might want to pose to a CRO, depending on your needs:
What other therapeutic areas do they deal with? What other stage clinical studies do they run?
What is the split between Phase I, II and III?
How many CROs should a small company evaluate? I say three. Two is the least amount. Three gives you an idea of the difference and differentiation between the CROs.
I’m often asked whether you should stay with the same CRO after you have selected them. My answer is yes, as you build a rapport with that company the longer you are with them which improves the working relationship.