Too often, sponsors facing enrollment challenges in specific regions are forced into a false choice: accept the delay or close the country. But there’s a better path. Confidence Pharmaceutical Research helps sponsors preserve their global footprint by replacing underperforming CROs or site networks with focused, region-specific solutions—reviving enrollment without sacrificing time or geography.

Switching to Confidence means a smooth, proven transition. Whether a sponsor needs to change CROs in one country, across regions, or at the global level, our team makes the process easy, minimizes disruption, and designs a rescue strategy tailored to the situation.

This installment of our Rescue Studies series explores an alternative to abandoning key markets: replacing local CROs or underperforming site networks with focused, data-driven interventions. We’ll walk through our regional rescue model—from feasibility re-assessment to seamless takeover to targeted site revitalization—and highlight how even one strategic pivot can realign a global study for success.

When Regions Lag, Rethink—Don’t Retreat

Country-level delays can have outsized impacts on global timelines. Yet too often, decisions to exit a region are made without fully understanding the root cause. From our experience, regional struggles usually stem from one or more of the following:

• High CRA turnover locally, or lack of oversight
• Poor communication between regional monitors and global teams
• Site disengagement or delayed activation due to contracting and regulatory bottlenecks
• Poorly organized logistics in the region
• Inaccurate feasibility assumptions that failed to account for real-world patient access

Shutting down a country, or the whole region, prematurely can be costly—not only in terms of lost enrollment potential and sunk costs associated with start up, but also in rebalancing enrollment, and delaying downstream milestones.

Instead of fully exiting underperforming regions, in some cases, we implement a focused rescue strategy that stabilizes operations and accelerates site-level performance.

Second-Opinion Feasibility as a First Step

Before any changes are made, we conduct a targeted second-opinion feasibility reassessment. This isn’t just a re-run of initial assumptions—it’s a reality check based on live study data and site feedback.

We evaluate:

• Site activation timelines and contract status
• Enrollment-to-date vs. projections
• Communication frequency, CRA support, and escalation pathways
• Local recruitment infrastructure and referral dynamics

We also directly engage with site staff—asking the kinds of questions that reveal both practical barriers and motivational gaps. The goal isn’t just to collect data; it’s to listen, validate, and recalibrate.

This diagnostic step not only informs whether to keep, replace, or add sites, but also gives sponsors clear guidance on what needs to be done to make a CRO switch successful.

Efficient Transition: Replacing Without Disrupting

Taking over a single region mid-study requires precision. The Confidence team has deep experience managing country- and regional-level CRO transitions without compromising the integrity of the broader trial.

Key elements of our Regional Rescue Protocol are described in an SOP and include:

• Sponsor-CRO Handoff Planning
  Clear scope definition, risk mapping, and alignment on shared goals
• CRO Team Integration

Depending on the SOPs and plans used in a study, Confidence regional team fully integrates into the study global systems. It may become a part of existing organizational frameworks (reporting lines and global calls), or may be managed as a separate unit by the sponsor–our Project Managers are experienced in both modes of integration.

• Regulatory and Contractual Updates
  Local ethics submissions, site re-approvals, and CTA amendments managed through our regional regulatory experts
• Site Re-onboarding and Engagement
  Personal outreach to each site, explaining the transition, reinforcing sponsor commitment, and resetting operational expectations

We don’t just “take over.” We guide sponsors through the handover, making the CRO switch smooth and painless while restoring trust at the site level.

From Stall to Surge: Site Revitalization in Action

Once transitioned, our Site Engagement Task Force activates. Drawing from our experience in full-scale rescue studies, we deploy country-specific strategies to stabilize and accelerate site performance.

These may include:

• Retraining new CRAs and re-training the site staff on protocol execution if necessary 
• Introducing new referral pipelines or recruiting sub-investigators
• Reactivating dormant sites or replacing those unwilling or incapable to re-engage
• Implementing customized communication plans—weekly touchpoints, newsletters, and centralized escalation channels

Case-study 

Real-world results from the APEX study regional rescue engagements.

In a Phase 3 study of a novel anticoagulant in acutely ill hospitalized patients, two Eastern European countries with 58 sites had enrolled only 284 patients over 14 months. When Confidence stepped in, our team identified the following issues: 

• Significant delays in site activation
• Site payments delayed up to nine months
• Inconsistent communication from legacy CRAs
• ~15% of sites lacked access to the target patient population
• Consent challenges for paralyzed or unconscious patients

To turn the situation around, Confidence implemented a focused rescue strategy that included:

• Conducting direct discussions with every site to assess potential
  
• Closing non-viable sites and replacing them with high-access centers
  
• Expanding the region by adding three additional countries, increasing total sites from 58 to 86
  
• Accelerating activation of new sites through a focused startup team and locally connected CRAs
  
• Building a new CRA team with prior experience at the same sites, strengthening communication and oversight
  
• Adapting ICF language to align with local regulations and allow ethical consent for acutely ill patients
  
• Stabilizing and streamlining site payment processes
  
  

As a result, the study regained momentum:

• 86 active sites across the region
  
• 1,956 patients enrolled in the following 21 months
  
• Enrollment rate more than tripled, restoring progress toward global timelines

When (and Why) to Consider a Regional Rescue

Not every study needs a full CRO change—but many would benefit from a targeted, country-level course correction. Sponsors should consider a regional rescue if they observe:

• Little or no enrollment from certain countries, despite active sites
• Feedback from sites suggesting lack of support or misaligned expectations
• Significant local CRO staff turnover or missed KPIs
• Repeated delays in site activation, contracting, MoH or EC approvals

Instead of walking away from a region, sponsors can engage a CRO with the precision and experience to stabilize what’s working and reconfigure what’s not.

Whether the problem is one country, one region, or the entire global program, Confidence can step in as the new CRO—making the switch seamless and ensuring execution that brings the study back on track.

Looking Ahead

The global landscape of clinical trials is too complex to rely on one-size-fits-all solutions. At Confidence, we treat every underperforming region not as a lost cause, but as an opportunity—to ask smarter questions, mobilize faster action, and restore value where others might retreat.

And we’re not limited to one geography. Switching to Confidence means having a CRO partner who can execute rescues at any scale—regional, global, or provider-level—designing and delivering strategies that stabilize, accelerate, and ultimately bring trials back on track.

In the next installment of our Rescue Studies series, we’ll explore how Confidence executes full-scale global study rescues—getting struggling trials back on track through focused site engagement, restructured oversight, and the systematic replacement of what’s no longer serving the study.

From replacing CRAs and retraining site teams to reorganizing referral networks and replacing underperforming sites, we’ll share how our structured model turns study-wide stagnation into renewed progress.

Stay tuned as we break down our Reengage–Reorganize–Retrain–Replace–Repeat framework, and share lessons from real-world turnarounds.