Clinical Researcher—December 2025 (Volume 39, Issue 6)
SITES & SPONSORS
Rend Williams, MPH, PMP
For many study sponsors, particularly small to mid-sized biotechnology and pharmaceutical companies, oversight of the contract research organizations (CROs) with which they partner on projects is one of the most challenging aspects of running clinical trials. Too often, oversight becomes either hands-off neglect, where sponsors assume the CRO will “just handle it,” or suffocating micromanagement, where every report and decision is second-guessed. Neither approach works. One leads to quality gaps and delays; the other erodes trust, increases turnover, and creates unnecessary conflict.
The truth is simple: compliance is only the starting point. Effective oversight is about building systems and relationships that ensure quality while also empowering CRO partners to perform at their best. In my experience leading clinical operations across oncology, hematology, and rare disease trials, the sponsors who succeed are the ones who strike the balance between accountability and trust.
Below is a framework I use with clients and teams—a model for sustainable CRO oversight built on four pillars: Clarity, Metrics, Communication, and Culture.
Clarity: Start with Expectations, Not Corrections
The foundation of good oversight is clear, upfront alignment. Too often, issues arise not because the CRO lacks capability, but because scope and expectations were never fully agreed upon at the beginning.
Sponsors should invest time early in defining:
- Deliverables: What success looks like in concrete terms.
- Decision Rights: Who makes the call on key operational and quality decisions.
- Escalation Pathways: How issues should be raised and resolved without delay.
This avoids the all-too-common pattern of endless corrections after the fact. When roles and outcomes are explicit, CRO teams know where they stand and can deliver without second-guessing every move.
Metrics: Measure What Matters
Oversight often collapses under the weight of the wrong metrics. Some sponsors still rely heavily on activity measures, number of monitoring visits completed, number of meetings held, and number of deviations flagged. These don’t necessarily correlate with trial success.
Instead, sponsors should focus on outcome-based metrics that reflect quality and progress, such as:
- Site activation timelines planned versus actual
- Monitoring visit effectiveness (issues resolved at first pass)
- Protocol deviation trends and corrective action timeliness
- Data entry and query resolution trends
- Investigator and site satisfaction feedback
When metrics align with outcomes, oversight becomes less about nitpicking and more about managing performance in ways that drive the trial forward.
Communication: Replace Firefighting with Structure
Many sponsor–CRO relationships fall into a cycle of crisis calls and reactive e-mails. Structured communication can break that cycle.
Best practices include:
- Standing Governance Meetings: Monthly or quarterly sessions that review performance, metrics, and risks at a strategic level.
- Regular Operational Touchpoints: Biweekly or weekly check-ins with the project team, focused on execution and problem-solving.
- Clear Documentation: Agendas, minutes, and follow-up actions to ensure accountability.
The key is consistency. When communication is predictable and structured, both sponsor and CRO teams spend less time reacting and more time planning.
Culture: Build Trust, Not Fear
The final, and often most overlooked, pillar of oversight is culture. Even the most sophisticated systems fail if the sponsor–CRO relationship is defined by mistrust or adversarial dynamics.
Sponsors can shape culture by:
- Acknowledging Wins: Recognizing when CRO teams meet or exceed expectations.
- Framing Feedback Constructively: Positioning oversight as support and alignment, not punishment.
- Modeling Accountability: Holding internal sponsor teams to the same standards expected of the CRO.
Don’t Forget CRO Contributions
However, culture is a two-way street. CROs play a key role in shaping it as well.
CROs can strengthen collaboration by:
- Practicing Transparency: Proactively communicating risks, delays, and challenges early, with solutions in hand. This builds credibility and prevents surprises.
- Owning Accountability: Taking responsibility for deliverables, performance metrics, and corrective actions rather than shifting blame. Accountability earns respect and keeps oversight focused on progress, not policing.
Trust is built when CRO leaders know they are partners in success, not just vendors under scrutiny. When both sides embrace transparency and accountability, the result is stronger engagement, lower turnover, and more effective problem-solving when issues arise.
Moving Forward: From Compliance to Partnership
The regulatory requirement for sponsor oversight is clear: you can delegate tasks, but you can’t delegate responsibility. What’s less clear, and far more critical, is how to build oversight systems that meet regulatory expectations without overwhelming teams or stifling progress.
By focusing on clarity, metrics, communication, and culture, sponsors can move beyond reactive, compliance-driven oversight and into a model that drives both quality and trust. This shift is especially important for smaller companies that may not have large operations departments. A structured yet balanced approach allows them to stay compliant, deliver on timelines, and build partnerships that last.
Oversight done right isn’t about control, it’s about alignment. And when sponsors and CROs are aligned, patients benefit most.
Rend Williams, MPH, PMP, (Rend@rwforesight.com) is Founder and President of Foresight Business Consulting, LLC, a San Diego, Calif.-based company with a mission of helping biotechnology and life sciences companies bridge the gap between their internal teams and CRO partners.
