There’s Room at the Table

Clinical Researcher—September 2018 (Volume 32, Issue 8)


Jim Kremidas

Think about the last special occasion you enjoyed at a favorite restaurant. Maybe it was a birthday. An anniversary. Or maybe you just decided to treat yourself to great food in a nice atmosphere with attentive and helpful wait staff.

Perhaps the host found you a nice corner table. The waiter may have suggested a personal choice about one of the specials. Later, the sommelier stopped by the table to give you some background on the seasonal wines on the menu.

If everything went smoothly, you benefited from a quality team of professionals functioning individually and together to produce excellent results.

Sound familiar? It should. Effective clinical trials are all about teamwork, too—on the parts of principal investigators (PIs), clinical research coordinator (CRCs), clinical research associates (CRAs), data managers, regulatory affairs specialists, institutional review board members, and many more. Clearly, clinical trials require a lot of moving parts and disparate skills to come together as a seamless unit.

I won’t belabor the restaurant-clinical trial metaphor (Who’s the chef? Who’s the maître’s d?), but I think it illustrates the point: As with any complicated operation, teamwork is vital in clinical trials.

Perhaps this is where the comparison ends, though. At that fancy restaurant, a weak link can mean a bad Yelp review, or at worst an inspection from the health department. During a clinical trial, a weak link can be far more serious.

Nothing “Soft” About It

Teamwork is what’s called a soft skill, but it’s actually very hard—hard to quantify, hard to demonstrate a tangible return on investment from, and hard to get right and keep right for prolonged stretches of time. However, common sense tells us stronger teams produce better results. In the clinical trial world, this translates into more efficient trials saving money and safely speeding critical and innovative drugs, devices, and therapeutic methods to patients who are anxiously awaiting new reasons for hope.

Just as the importance of teamwork cannot be overstated, so to is the value of industry-wide standards and certifications as an important foundation. CRCs, CRAs, and PIs are just three of the key components of a clinical trial. It’s time for us to come together as an industry to further professionalize our outstanding workforce. We can raise the clinical trial industry to new heights if we band together to craft and implement a robust series of standards where, together, we are leveraging the latest best practices and tools in our day-to-day work.

As always, I welcome your thoughts. Please don’t hesitate to reach out to me at the address below.

Jim Kremidas ( is Executive Director of ACRP.