The working relationship between a Sponsor and CRO is dynamic, fluid and ever changing. It is often one of the most crucial decisions a Sponsor needs to make when assessing their clinical and regulatory path in new drug development. Why is it, that like a marriage, some CROs and Sponsors ‘click’ immediately and others face the rocky road of disharmonious discord from day one? There are 5 easy tips for any Sponsor looking at entering into a relationship with an unknown CRO, somewhat like online dating. The Sponsor needs to make sure their CRO is going to fit into the existing dynamic of their company and has the expertise to take their product through the clinical and regulatory pathway.
Tip 1: The Interview. When choosing your CRO make sure you meet all members of the team that are going to be working with you and your team. Evaluate personality types and level of expertise. Don’t judge a CRO on a first time sales pitch or presentation; you need to see how they work in the long run.
Tip 2: Refer, refer, refer. The world of drug development is a small one, and chances are someone you know, knows someone who knows someone at the CRO in question. Don’t be bashful, make the call and let your colleague know who you are considering. Best you find out before a contract is signed what the word on the street is.
Tip 3: Experience, experience, experience. No matter what anyone tells you people are human and the tendency to exaggerate or magnify their accomplishments is a natural inclination. When looking for a CRO make sure they are qualified in your area of expertise. The range of knowledge at a proficient CRO is often mindboggling but do your due diligence. If a CRO is only adept at Phase I/II trials and you are hoping they take you all the way to Phase IV, make sure you ask how they plan to get you there.
Tip 4: Size doesn’t matter. Small, medium or large, what CRO is the right one? Again, look at the qualifications of the team you want and who can best provide them. Sometimes a small CRO dedicated only to your project is the perfect fit. Sometimes a multi-national CRO able to provide a network of expertise around the globe will fit into your budget and development plan. Again, look at the “who” behind the logo and mission statement, and make sure you are buying a person with expertise, not a corporate image.
Tip 5: Blending your family. This may seem like the most silliest of points so far, but it is the most important. Make sure that all members of your team get a chance to speak to their counterpart on the CRO team. Nothing stirs up a blended family like insecurity and jealousy. Often Presidents, CEOs and Chairman of the Board are responsible for the final say in which CRO will get the project, which on a corporate level is a sound decision, but remember the dynamic. Co-operation between CRO and Sponsor is vital in getting both up to speed and a project completed. If a team member on either side feels threatened or put-out by the additions to their team the whole project can be derailed in a matter of ill-timed emails and sarcastic comebacks. Do your best to let your team know that a CRO is only an asset and not a commodity.