LET'S MAKE IT CLEAR:

A Series About Strengthening the Sponsor-CRO Relationship

Selecting a CRO
Cari KniolaSenior Director, Corporate Strategy
April 12, 2022

Selecting a CRO is one of the most important choices a sponsor will make for their company and the future of their product.

No pressure, right??!!

This may sound dramatic, but selecting a CRO that is not a fit can impact everything from budgets and timelines all the way to data quality and even patient safety. And the time between the honeymoon period and the realization that the relationship is at the end of its rope is a period of stress and animosity that will keep both sides up at night.

So how does this misaligned partnership happen? One of the biggest culprits I have seen over my nearly 25 years in the industry is that the CRO selection process is left to the very end. By this time the protocol is written, investors and stockholders have been told when FPI is happening, and the protocol is getting ready to go to the regulatory agencies. The engines are revving and waiting for that green flag! The sponsor needs a CRO, and they need that CRO to start yesterday!

When the selection of a CRO is the last step, it forces a speed dating situation. In a short amount of time during a high-stress period of product development, sponsors are selecting a CRO partner that they will be with every day for the foreseeable future. It’s like having the CROs sit in a loud bar, with sponsors going from table to table to try to find out as much as they can about them in 5 minutes, then using this little bit of distracted information gathering to make a decision that will tie you together for the next several years (and millions of dollars).

Here are 5 tips to help sponsors avoid a speed dating situation and get the information they need to make an educated decision when selecting a CRO partner:

1) Talk to the CROs before you submit the RFPs: When I say ‘talk to the CROs’ I don’t mean just the BD reps – they are a crucial contact and guide through the CRO selection process. But you also want to talk with others from the CRO in order to get a feel for their company culture and see if there is chemistry. Chemistry? Yes, chemistry. This is a relationship, remember? If you meet with functional area management even for just a general capabilities discussion, you can start to get a feel for whether this is a group you could see yourself working with in the future. A ‘click’ between company cultures and personality goes far, in particular when faced with adversity.

2) Provide a well-thought-out RFP: Not only does rushing the CRO selection process put the CRO in a crunch to get you information about them, it puts you in a crunch to get the CRO a RFP that will give them enough information to provide a proposal that is an accurate reflection of what it will take to do your project. Future blogs will dive deeper into what constitutes a good RFP, but even if it is early in the process – and you are still finalizing the protocol and figuring out the big picture – you can give CROs projected timelines, the protocol synopsis, and the scope of services, so they at least can be on the same page with your team at the current moment. That page may be edited in the future, but you and the CRO can work through that together. What is important at this stage is they have a clear enough idea of what you are looking for in a partner, so they can start to assemble the picture of how they could be a great match.

3) Give CROs enough time to submit a proposal: Like a bad first date, a common complaint we hear from sponsors that were unhappy with their CRO is that the picture painted in the proposal is not what they ended up with. They feel like they were swindled, and the relationship goes downhill from the start. In some cases, this is a true catfish situation – a CRO will apply the ‘low cost study’ filter to get the work, and then once awarded the filter is turned off and the change orders start flowing. However, sometimes CROs want to give you the real picture of who they are and how they would conduct your study but aren’t given enough information and/or enough time to put together a thorough, thoughtful, and accurate proposal. Ten business days may sound like a lot of time to put together a proposal (especially if you are faced with tight timelines), but when you factor in meetings for the CRO team to review the RFP materials, asking you questions and giving you time to respond, operationalizing how the study would be conducted, getting vendor quotes,  putting together a budget, writing a proposal document – it is a tremendous amount of work, with valuable input needed from functional areas whose ‘day jobs’ are not proposals. Giving a CRO at least three weeks to submit a proposal will help ensure you are getting the best reflection of what they think will be required to deliver you a quality study.

4) Give yourself enough time to review the proposals: Proposals are like a Match.com profile – they provide you with valuable information, but you need to give yourself time to dig deep and absorb the details to get a good impression of who the CRO really is. These documents are pages and pages long and can be overwhelming to review! But they include critical details and insights into how the CRO plans to conduct your study. They tell you about the team that would potentially be running your trial, CRO experience, and any insights they might have into potential study risks or considerations for a different approach. When you are comparing proposals received from multiple CROs, you have to have enough time to absorb the information they have provided, both from a big picture of experience and study input as well as the details of their budget. You also need to give yourself enough time to ask questions, which could potentially lead to adjustments in their budget (which also takes time!).

5) Give everyone time to properly prep for the bid defense: The time for casual dating is done, and it’s getting really close to making the relationship official. The bid defense is the CRO’s final opportunity to show you who they are and why they would be the ideal mate. And it is you and your team’s final opportunity to ask your questions, see if that chemistry is still there, and determine if the CRO has what it takes to really be ‘the one’. It’s like bringing your date home for the holidays to meet the family – you think this person is pretty awesome, but you need buy-in from those important to you in order to really seal the deal. Like everything else up to this point, be sure to give adequate time not only for the CRO to prep for this bid defense, but also to give your team enough time to get up to speed on the CROs and their proposals and have time to formulate their own questions based on what they see. Let the CRO know who will be at the bid defense, and what sort of information each member of your team will want to know. This ensures a productive meeting that digs past the superficial stuff and into the details that will help you make the critical choice of CRO partner.

With any serious, long-term relationship, it takes time to get to know each other – the Sponsor-CRO relationship is no exception. When the partnership is approached with thoughtfulness and intent from the start, it sets the expectation for future interactions. Give yourself time to get to know and understand your future partner and what they have to offer, so when you make that CRO choice you will have confidence you have looked past the superficial and found the partner that is ‘the one’.

Ready to start the search for ‘the one’? Join us for our next blog ‘Submitting a RFP to Get the Proposal You Need’ and learn how you can use your RFP to see if your CRO checks the right boxes for a successful long-term partnership.

Cari Kniola

Senior Director, Corporate Strategy

Cari’s role in Corporate Strategy includes working with the C-Suite in developing and executing strategic corporate development and growth as well as oversight of marketing and proposals.

Cari has nearly 25 years of clinical research experience in both pharmaceutical and medical device studies. During her career she has served in various operations roles, including study coordinator, CRA, clinical trial manager and eight years in project management. Her experience has included roles with sites, sponsors and CROs, and she understands the challenges that each face. For the last several years, Cari’s role has focused on the corporate side of clinical research, using her operations experience and business acumen to drive corporate strategies, marketing, and proposals.

When not planning Aperio’s next move, Cari spends her free time strolling on the Lake Michigan shoreline, hiking in the Indiana Dunes, and fulfilling her obsession with LEGOs.

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