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Five Common Challenges in Clinical Study Execution — And How an Integrated CRO Solves Them

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Five Common Challenges in Clinical Study Execution — And How an Integrated CRO Solves Them

19.12.2025

Clinical research has always been complex, but today’s trials are more demanding than ever. Sponsors must navigate rising regulatory scrutiny, ambitious timelines, global patient recruitment requirements, and advanced scientific endpoints—while ensuring impeccable data integrity and operational consistency. Despite major advancements in technology and study design, clinical trials still face persistent obstacles that slow progress, increase costs, and jeopardize outcomes.

However, one solution consistently proves effective across trial types and therapeutic areas: integrated CRO models—especially those that operate their own clinical research sites. By combining strategic oversight with hands-on execution, integrated CROs eliminate fragmentation, reduce delays, and create a seamless operational flow that improves overall study performance.

This article explores five common challenges in clinical study execution and explains how integrated CROs help sponsors overcome them.

1. Challenge: Slow Study Start-Up and Site Activation

Study start-up is one of the most time-intensive parts of a clinical trial. The process typically includes:

  • Feasibility assessments
  • Site selection and qualification
  • Budget and contract negotiations
  • Regulatory submissions
  • Training and system onboarding
  • Site initiation visits

Even small bottlenecks during this phase can cause significant downstream delays. In traditional models, multiple vendors and independent sites mean more hand-offs, more miscommunication, and more waiting.

How Integrated CROs Solve This

Integrated CROs accelerate start-up by streamlining steps that normally happen sequentially:

  • The clinical site is already pre-qualified and active.
  • SOPs, systems, and quality frameworks are unified.
  • Regulatory teams can submit documents immediately.
  • Site contracts are simplified because the CRO and site are part of one organization.
  • Staff are pre-trained and ready for study-specific onboarding.

As a result, activation timelines can be reduced by 30–60%, enabling faster first-patient-in (FPI) and stronger overall study momentum.

2. Challenge: Slow or Inconsistent Patient Recruitment

A staggering 85% of clinical trials experience delays due to slow enrollment, and nearly one-third of sites fail to enroll even a single participant. Recruitment challenges often stem from:

  • Overly optimistic feasibility estimates
  • Limited site engagement
  • Competing trials at academic centers
  • Lack of direct patient relationships
  • Recruitment strategies that are not tailored to the local population

Without adequate enrollment, even the most promising study cannot move forward.

How Integrated CROs Solve This

Integrated CROs that operate their own clinical sites have a major advantage:
direct access to patients and established community relationships.

Benefits include:

  • Realistic feasibility assessments based on historical enrollment data
  • Tailored recruitment strategies rooted in local population insights
  • Reduced competition for eligible patients
  • Faster referral pathways with local physicians
  • Immediate access to diverse patient pools
  • Optimized workflows for screening and enrollment

These elements increase enrollment speed and improve retention, helping sponsors stay on schedule.

3. Challenge: Communication Breakdowns Between CRO, Site, and Sponsor

Traditional trials often involve multiple vendors:

  • CRO
  • Central lab
  • Clinical site
  • Logistics providers
  • Data management team
  • Monitoring team
  • Biobank
  • Sponsor

With so many stakeholders, even small miscommunications can lead to:

  • Delayed decision-making
  • Missed queries
  • Data inconsistencies
  • Deviations that go unreported
  • Lack of real-time visibility

Fragmented communication is a major contributor to operational risk.

How Integrated CROs Solve This

An integrated CRO with an on-site clinical research team eliminates unnecessary layers of communication.

Benefits include:

  • CRO teams and site teams working under one operational framework
  • Real-time interaction between monitors, coordinators, and investigators
  • Immediate escalation and issue resolution
  • Shared systems for data, sample tracking, and scheduling
  • Consistent protocol interpretation across all study staff

This alignment creates a smoother trial environment, reduces errors, and ensures sponsor updates are timely and accurate.

4. Challenge: Inconsistent Quality and Protocol Deviations

Quality issues remain one of the biggest risks to study validity. Common causes include:

  • Sites following different SOPs
  • Inconsistent training
  • High coordinator turnover
  • Misinterpretation of protocol requirements
  • Weak quality oversight
  • Poor documentation practices

Even minor deviations can undermine scientific integrity and lead to expensive corrective actions.

How Integrated CROs Solve This

Integrated CROs centralize and standardize quality oversight:

  • Unified SOPs cover both CRO and site operations.
  • Coordinators and investigators receive consistent training.
  • Quality teams proactively monitor data and source documents.
  • Issues are identified and corrected early.
  • Real-time oversight ensures deviations are prevented, not just reported.

Because the same organization controls both study execution and management, accountability is clear and quality is continuously enforced.

5. Challenge: Biospecimen Handling and Data Integrity Issues

As diagnostics and precision medicine expand, biospecimen quality has become mission-critical. Yet many studies fail due to:

  • Mishandled samples
  • Missing chain-of-custody documentation
  • Improper storage temperatures
  • Inconsistent labeling practices
  • Delayed shipping and processing
  • Missing data points
  • Errors during EDC entry or reconciliation

Each of these problems jeopardizes study validity.

How Integrated CROs Solve This

Integrated CROs excel in sample-driven and data-heavy studies because:

  • Collection, handling, and storage all occur under a single:
    • SOP structure
    • Quality system
    • Oversight team
  • Sites use validated equipment and temperature-controlled storage.
  • CRO teams monitor sample handling in real time.
  • Direct communication ensures immediate resolution of any issue.

Integrated models dramatically reduce error rates and ensure biospecimen integrity from collection to analysis.

Additional Benefits of the Integrated CRO Model

Beyond addressing the major challenges above, integrated CROs offer numerous strategic advantages.

Faster Turnaround for Queries and Monitoring

Because the site and CRO use aligned systems, queries are resolved quickly and datasets remain clean.

Improved Cost Efficiency

Integrated models reduce:

  • Repeated trainings
  • Duplicate SOP structures
  • Vendor fees
  • Inefficient hand-offs

The result is leaner, more predictable operational budgets.

Real-Time Operational Oversight for Sponsors

Sponsors gain visibility into:

  • Enrollment performance
  • Data trends
  • Sample collection
  • Protocol deviations
  • Quality metrics

Better visibility means better decision-making.

Stronger Patient Experience

Patients benefit from:

  • A consistent, well-trained team
  • A welcoming and efficient study environment
  • Clear communication
  • Faster visit times
  • Personalized care

A positive patient experience improves retention and lowers dropout rates.

Conclusion

Clinical trials face a multitude of challenges—from slow enrollment and communication gaps to inconsistent quality and complex biospecimen requirements. Traditional CRO–site structures often struggle to overcome these obstacles efficiently. In contrast, integrated CRO models, especially those with in-house clinical research sites, offer a strategic solution.

By combining centralized oversight with hands-on execution, integrated CROs streamline study start-up, accelerate recruitment, improve data integrity, and reduce operational risk. They eliminate unnecessary hand-offs, enhance communication, and maintain consistent quality across every step of the trial.

For sponsors seeking faster timelines, better outcomes, and more predictable study performance, integrated CRO partnerships are not just an option—they are an increasingly essential strategy for modern clinical research.