I've participated in more vendor selections than I can count, and one topic almost always finds its way to the center of the discussion: therapeutic area experience.
How many studies has the vendor completed in this indication? How experienced is the proposed team? Have they worked on similar protocols? Do they know the investigator landscape?
Those questions make perfect sense. Clinical trials are expensive, timelines are tight, and there is comfort in knowing that the people supporting the study have seen something similar before.
Still, over the years, I've found myself paying closer attention to a different set of factors. Not because therapeutic area expertise isn't valuable, but because I've watched studies succeed and struggle for reasons that had very little to do with therapeutic area knowledge.
Why Experience Gets So Much Attention
Part of the appeal is that experience is easy to discuss.
A vendor can tell you how many studies they've supported in a given indication. They can describe previous programs, highlight key accomplishments, and introduce team members who have spent years working in a particular therapeutic area.
All of that information is useful. It belongs in the conversation. The challenge is that some of the characteristics that influence study outcomes are much harder to evaluate during a selection process.
Consider the following:
How well does the team work together when timelines start slipping?
How quickly do issues move from identification to action?
How does the team react when assumptions prove wrong?
What happens when enrollment falls behind plan?
How effectively do sponsor and vendor teams communicate when difficult decisions need to be made?
Those questions are harder to answer in an RFP or a bid defense. Yet they often become far more important once the study is underway.
An Observation From My Career
Years ago, I moved into oncology without prior oncology experience.
There was plenty to learn. I had colleagues who understood the science, treatment landscape, and disease-specific considerations far better than I did. I leaned on them heavily and learned a tremendous amount from them.
At the same time, I wasn't entering an unfamiliar profession. By then, I had already spent years working in clinical operations. I had managed studies, worked with sites, overseen vendors, navigated delays, handled escalations, and spent more than enough time dealing with situations that rarely go according to plan.
Looking back, what helped me most during that transition wasn't a textbook or a certification. It was the accumulation of experiences from studies that had very little to do with oncology.
The details were different.
The operational challenges often weren't.
Sites still needed support. Teams still needed alignment. Risks still needed attention before they became larger problems. Progress still depended on communication, coordination, and execution.
That experience has shaped how I think about project teams today.
What I've Seen in Strong Teams
Some of the strongest teams I've worked with have supported studies across multiple therapeutic areas. Over time, they accumulate a broad collection of experiences, and those experiences tend to show up in subtle ways.
They recognize warning signs earlier. They ask different questions.
They spot connections between situations that may appear unrelated on the surface.
A startup delay in one study may remind them of a resourcing issue they encountered somewhere else. A site performance challenge may resemble something they saw years earlier in a completely different therapeutic area.
The details rarely match perfectly, but the experience remains useful.
I've seen teams draw on lessons from dozens of prior situations and apply them to a problem they had never encountered before. That kind of judgment is difficult to quantify, but it's hard to miss once you've worked with people who have it.
The Parts of Vendor Selection That Are Hard to Measure
One reason therapeutic area expertise receives so much attention is that it fits neatly into an evaluation framework.
You can compare:
Number of studies completed
Years of experience
Similar protocols supported
Investigator relationships
Geographic reach
Those are useful data points, and most selection teams should consider them.
The difficulty is that many of the qualities that influence day-to-day study performance don't fit neatly into a spreadsheet.
Judgment doesn't. Adaptability doesn't. Team chemistry doesn't.
The ability to stay calm when unexpected problems arise doesn't.
Anyone who has spent enough time in clinical operations has probably worked with teams that looked outstanding on paper and teams that exceeded expectations despite having less obvious credentials. Those experiences tend to leave an impression.
Keeping Experience in Perspective
Therapeutic area expertise will always be an important consideration, and there are certainly situations where it becomes a significant advantage. Some indications bring unique scientific, operational, and regulatory complexities that require specialized knowledge.
At the same time, most studies eventually encounter challenges that aren't specific to a therapeutic area at all. Delays, staffing changes, communication issues, competing priorities, enrollment pressures, and operational surprises can emerge almost anywhere.
When those moments arrive, project teams often rely on capabilities that extend well beyond indication-specific knowledge.
That's one reason I've become increasingly interested in the broader experiences a team brings to the table. Not just what they've done within a particular therapeutic area, but what they've learned across different studies, different environments, and different challenges.
Those experiences don't always appear prominently in a proposal or a bid defense presentation.
They often become visible later, when a team is asked to navigate a situation that nobody anticipated during vendor selection.
And those are usually the moments that tell you the most about the team you've chosen.
About the author:
Kalyan Obalampalli (KO) is a disruptor and technology innovator with over 20 years of experience in leadership positions in Clinical Operations and Outsourcing at major pharma and biotechs. Having served in advisory roles at start-ups in Silicon Valley, Kalyan has a unique perspective on Clinical Development Operations and how technology can help fill gaps.
Kalyan is the Founder and President of Clin.AI, a disruptive start-up that is revolutionizing the way vendor selection and management is conducted in the biotech / pharma space.
