CONTRACT RESEARCH ORGANISATIONS I


have heard very often in my career, especially when I have been employed at sponsor companies: “How do you find


a CRO?” or “How do you pick a CRO?” or “Who do you like to work with?” What loaded questions! I found a CRO right on my front doorstep. I pick fruit, not CRO partners. I like to work with my hands. CROs deserve and desire a true partnership,


not a transactional relationship. Your next product or asset is your baby, and you want a partner who can manage and care for that asset as if it were their own.


That said, I am a department of one in a small biotech company outside of Boston, Massachusetts. So, how do I identify and select a CRO partner that is the right size for me? Here is what I believe we do as an industry. We ask our co-workers, friends, colleagues and so on. We do internet searches. We read articles or annual CRO report ratings. We work with people or businesses we have worked with before. Or we work with people or business we have heard of before – like a “big name” organisation.


There simply must be a better way. How do


you select someone to install a new appliance in your home? Find a tutor for your child? Decide which hotel to stay in?


ABC, Do-Re-Mi, RFP


It all starts with the request for proposal (RFP). But that RFP has to be inclusive and detailed and express the depth and breadth of what you need very clearly. Here are the areas I focus on: • therapeutic area expertise • geographic area expertise • site identification and selection • vendor management and QA • contracting/finance • compliance/regulatory • timeline management • risk management and risk sharing • team composition • Trial master file (TMF) considerations These are the modules I include in the RFP: assumptions; timeline/milestones; roles and responsibilities (R&R); questions and answers (Q&A).


The R&R


Mine is quite detailed – it can encompass seven to 10 pages of subtasks under each functional area, and outlines the party responsible for each task.


The Q&A


Here is where I determine what types of communications are essential for success by prioritising the: • Kick off meeting/launch process. Please make sure you make the time to plan every detail out before the ship leaves the dock. It is time well spent!


• Communication and setting expectations. I may think I am saying something that all parties understand intuitively but that is rarely the case.


• Clinical quality agreement. A great resource for such agreements can be found at ctti-clinicaltrials.org; theavocagroup.com; and lifesciencetraininginstitute.com


• Face-to-face meetings. See kick-off meeting, above, and be sure to schedule in advance of study start.


• Lessons learned. This puts the story of the study to bed, and ensures we do not make the same mistakes in the future to the degree we can control change.


Using technology to make your job easier So, how do you identify and select a CRO partner that is the right size for you? Here’s a case example. Clin.AI is a cloud- based platform, able to create, send and negotiate proposals based on standardised, best practice templates; able to provide artificial-intelligence-based data visualisation and comparison tools; and able to capture


“CROs deserve and desire a true partnership, not a transactional relationship. Your next product or asset is your baby, and you want a partner who can manage and care for that asset as if it were their own.”


Outsourcing in Clinical Trials Handbook | 21


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