Five P's For A Productive CRO Relationship

By Ed Miseta, Chief Editor, Clinical Leader

You have done the research and selected a CRO that looks like it can meet all your research needs. Now you are about to entrust your precious samples to a team of people you may barely know. How do you safeguard your research, meet your timelines, and develop a productive working relationship with your CRO?

For anyone in the position of managing clinical operations, few things are less stressful than managing these relationships. There are also no activities you perform that are more critical to the success of your trial. A good CRO can bring your project in on time, meet all regulatory requirements, and do so with the level of quality you expect. Unfortunately, choosing the wrong CRO can result in delays, poor quality, and the feeling that you have a CRO that will require constant monitoring and hand-holding.

Renold Capocasale, the CEO and founder of FlowMetric, knows that feeling well. He spent many years within pharma working with CROs before starting his own company and moving to the CRO side of the house. Being a scientist in his past life, Capocasale also knows how important it is to do due diligence when selecting a CRO.

Tapping into the knowledge of CROs that he has accumulated over the years, Capocasale shares these five P’s that every relationship manager should ponder if they want to get the most out of their scientific partners.

1. Prepare, Prepare, Prepare.

Selecting the right CRO takes time and due diligence. You should spend time researching what kind of CROs offer the services you need. Talk to someone at a prospective CRO about their services, expertise, turnaround times, and fees. It's also worth requesting the references of other customers who have used these CROs so you can contact them in person and get a better insight into the customer experience.

Capocasale also recommends creating a checklist of all the requirements you have for a CRO. Note which items on the list are most critical, and then check them off when meeting with perspective partners. Websites such as AssayDepot and Science Exchange will make this job a little easier. For smaller or boutique CROs, it is often easier to simply pick up the phone and call them. 

“I feel sponsors should consider completing a three-step process when making their selection,” says Capocasale. “Step 1 is talking to the CRO about your needs and capabilities. Step 2 is speaking with their actual lab scientists about your project. You want to know if this is something they have done before, or if it is a new assay that would have to be developed. Step 3 involves physically visiting the CRO’s site to see the professionalism of the staff and the cleanliness of the laboratory facilities. An in-person visit can generally give you a good feel for the culture of quality that exists, which you can’t get via a phone conversation or conference call.”

Capocasale also recommends not being afraid to ask for references. Although confidentiality agreements can often keep a vendor from disclosing that information, it is not impossible for a CRO to obtain a valid reference that does not break any such agreements. If no references exist, network connections could be a source of information. However, he cautions information on relationships is often held confidential by individuals involved in the trial.

2. Plan For Everything.

Communication is the bedrock of a successful relationship with a CRO and this begins when you explain what assays you need to be performed. Can they do these assays or do they need time for development? Can the CRO meet all the regulatory criteria in your protocol? Are you going to need samples assayed every two weeks over a several month period, or are you going to hand over several hundred samples in six months and require a quick turnaround? Details matter so no one is confused, frustrated or disappointed.

The number of meetings to be held with the CRO should depend on the level of difficulty of the study and the length of the project at hand. However, the basic plan for meetings with a CRO would be to have an initial meeting to understand capabilities and services, a second more in-depth meeting with the scientists to discuss your specific project once a Confidentiality Agreement is in place, a kick off meeting once the project is set to begin, and then periodic meetings (weekly or monthly depending on length and complexity) throughout the study.

“I would recommend face-to-face meetings as often as possible,” notes Capocasale. “I like to have one of these meetings at the onset of the project and at the completion of the project for delivery of the data package. Meetings by conference call are definitely second best, but are also a convenient way to hold periodic check-in’s with the CRO to ensure everything is on-track throughout the lifecycle of the project.”

3. Point Of Contact.

You will be exchanging large amounts of information with the CRO, and this two-way relationship is most successful when you have an open line of communication with a person responsible for managing your project within the CRO. Make sure you are comfortable working with this person and invest the time necessary to properly build the relationship.

In order to get more comfortable with the project manager, Capocasale again recommends a face-to-face meeting. “I find that being in front of a person can really give you insights on who they are and how they operate,” he states. “I always advise the client to be as open as possible with their expectations on how the relationship will proceed. By doing so, the CRO project manager can then tailor the relationship to best meet each client’s needs based on those expectations.”

If at any point the client is unsatisfied with the way the relationship with their CRO project manager is going, clients should reach out to the business development or sales rep that they initially connected with at the CRO. It is the job of the business development manager to make sure the project and the relationship between the CRO and client are running smoothly. That individual can also help clients to obtain a new manager for the project, if necessary.   

4. Pick A Time And Problem Solve.

You should schedule a regular meeting time with the CRO team to discuss progress, look at data, and troubleshoot issues that may arise. This type of meeting may happen in person, by web conference, or over the phone. Regular meetings help keep everyone in the loop and can prevent problems from languishing for weeks.

According to Capocasale, timelines should definitely be discussed upfront. “Discussing this upfront ensures the CRO will be clear about expectations and any deadlines that must be met,” he says. “During these discussions, the CRO must be clear and honest about their in-house capacity and ability to meet required timelines. It is fine for the client to ask for metrics on the CROs timeliness. Every CRO should have this data. If a CRO refuses to share that information with you, that may be because it has trouble meeting deadlines.”

When issues arise that will affect specific timelines, the CRO obviously needs to be upfront with the client about these delays and work with the client to decide the best path forward. That path might involve changing the current proposed study path or even stopping work on the study all together. 

5. Don’t Forget To Praise.

Finally, clients should not be reluctant to give praise when it is due. Good CROs invest significant time and capital into building high-quality operations staffed with experienced scientists and technicians. They also run their operations under the strictest standards.

“CROs can only continue offering their superior services if the research community and pharmaceutical industry supports them,” adds Capocasale. “If you have a great experience with your CRO, spread the word, and give credit where credit is due. They will appreciate the gesture and it will likely lead to a better and longer lasting relationship.”

Follow this prescription for a prosperous Client-CRO relationship!