Rethinking Site Selection for Commercial Research: Is Past Performance Enough?
For years, site selection has relied heavily on familiar indicators: investigator reputation, historical recruitment, previous collaborations and qualification visits.
But as clinical trials become more complex, is that still enough?
Increasingly, the conversation I'm hearing with sponsors, CROs and research organizations is changing. The question is no longer simply "Has this site delivered before?" It is becoming "Can this organization consistently deliver tomorrow?"
That subtle shift from measuring past performance to understanding organizational capability, could represent one of the most important changes in site selection over the next decade.
I recently shared some reflections on why investing in organizational quality is becoming a strategic priority for clinical research sites which you can read here.
Since then, I've continued thinking about the other side of that conversation. Not what sites should be doing…
…but what sponsors and CROs are increasingly looking for.
Over nearly 20 years working across clinical research, I've seen site selection evolve considerably. Recruitment capability, therapeutic expertise and Principal Investigator experience remain fundamental considerations. They always will.
However, those factors no longer tell the whole story.
Clinical research has changed. Protocols are more complex. Study teams are operating under greater pressure. Workforce turnover remains a challenge across many organizations, and expectations around governance, quality and operational resilience continue to grow.
Against that backdrop, the questions being asked are becoming noticeably different.
Instead of simply asking:
- Has this site recruited well before?
- Have we worked with this investigator previously?
- Did they pass their last audit?
I'm increasingly hearing broader organizational questions.
- Can this organization scale?
- How resilient is it if key members of staff leave?
- Is governance mature and consistent?
- Will quality remain stable across every study?
- How can we assess that confidence before awarding a trial?
These are not compliance questions. They are capability questions.
Compliance Gets You Started. Capability Builds Confidence.
Compliance remains non-negotiable.
Every research organization must operate in accordance with Good Clinical Practice, applicable regulations and sponsor expectations. That provides the foundation for safe and ethical research.
Capability is something different. Capability is the ability to deliver quality consistently; not only when a study begins or an audit takes place, but throughout changing workloads, staff transitions and increasingly demanding research programs.
It reflects leadership, governance, workforce competence, operational systems and organizational culture working together. Increasingly, these are the characteristics sponsors are trying to understand before making site selection decisions.
Looking Beyond Individual Performance
Historically, many site selection decisions have understandably focused on the experience of individual Principal Investigators.
Exceptional investigators remain one of the greatest strengths within our industry, yet successful study delivery has become much more dependent on the wider organization supporting them. An experienced investigator cannot compensate indefinitely for inconsistent governance, fragile processes or an overstretched workforce.
Likewise, a well-led organization with strong operational foundations is often better positioned to deliver consistently across multiple studies, therapeutic areas and sponsor partnerships.
The conversation is gradually moving from individual excellence towards organizational excellence.
The Challenge Is Evidence
This creates an interesting challenge - How do sponsors objectively evaluate organizational capability?
- Historical metrics are valuable
- Qualification visits are valuable
- Previous working relationships are valuable
But each of these primarily reflects the past. What many sponsors are increasingly trying to understand is future confidence.
- Can this organization continue delivering as studies become more complex?
- Can it adapt?
- Can it maintain quality under pressure?
- Can it grow sustainably?
These are more difficult questions to answer using traditional assessment methods alone.
Across healthcare and other regulated sectors, organizations are increasingly exploring ways to assess organizational maturity and operational capability alongside historical performance. It is a trend that aligns with broader industry thinking around quality management, quality by design and risk-based oversight reflected within ICH E6(R3).
A Conversation Worth Having
I'm not convinced the industry has fully answered these questions yet, but what I do believe is that the conversation has changed. Sponsors are no longer looking solely for sites that have delivered successful studies in the past; increasingly, they are looking for organizations that have the governance, leadership, workforce and operational maturity to continue delivering successfully in the future.
That feels like an important distinction.
So perhaps the real question isn't whether a site has delivered before, but whether we have the right ways to assess its ability to deliver consistently in the future.
As clinical research becomes more complex, should site selection continue to rely primarily on historical performance, or is it time to place greater emphasis on demonstrated organizational capability?
Vicky Toms | Executive Director of Business Growth and Oversight
Email: vtoms@iaocr.com