How Remote Monitoring Is Transforming Compliance and Operational Efficiency in Clinical Trials

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Introduction

Monitoring visits have always been a cornerstone of clinical trial oversight. For Investigational Drug Services (IDS) pharmacies, these visits ensure the safe handling, storage, and documentation of investigational product (IP) throughout the study lifecycle. Traditionally, however, these visits required extensive onsite presence, paperwork-heavy workflows, and hours of manual reconciliation, placing a significant burden on pharmacy staff and monitors alike.

As clinical trials evolve, so too has the approach to monitoring. A growing shift toward remote and hybrid models is redefining operational efficiency, improving documentation accuracy, and strengthening compliance. Today, sites that embrace digital oversight are better equipped to maintain audit readiness while reducing the strain of traditional onsite visits.

The Shift From Onsite to Remote Monitoring

The COVID-19 pandemic accelerated a change that was already emerging: remote monitoring as a practical, scalable solution for modern trials. Restrictions on travel and site access pushed organizations to adopt electronic drug accountability (eDAR) systems, eSource platforms, and digital documentation tools that enabled monitors to review essential records without being physically onsite.

This transition not only made monitoring more resilient during the pandemic but also revealed clear long-term benefits. Remote monitoring:

  • Streamlines scheduling and coordination
  • Reduces staff interruptions
  • Supports real-time documentation review
  • Enables continuous oversight instead of episodic, retrospective reviews

Today, remote and hybrid monitoring are not temporary solutions – they are the new standard.

The Role of Technology in Modern Monitoring

Modern monitoring practices rely heavily on digital systems that provide clarity, structure, and real-time visibility into trial operations. eSource platforms and cloud-based eDAR systems streamline the entire accountability cycle, from receipt and dispensing to patient returns and destruction.

Platforms like Vestigo® and Vestigo® Verify provide:

  • Structured monitor visit workflows
  • Automatic audit trails
  • Integrated communication tools
  • Role-based access with time-limited permissions
  • Real-time inventory visibility (including lots, kits, expiration dates)
  • Secure access to pharmacy documentation

These capabilities significantly reduce the need for manual verification and photocopying and allow monitors to complete thorough reviews without on-site disruption.

Regulatory Alignment with Risk-Based and Remote Monitoring

Regulatory bodies have embraced digital oversight and remote review. Guidance from the FDA and ICH supports risk-based monitoring (RBM), centralized review, and hybrid visit models, especially when digital systems provide accurate, real-time data.

Key regulatory frameworks highlight:

  • Prioritizing high-risk activities and data
  • Ensuring continuous oversight using digital tools
  • Using centralized data review to identify irregularities early
  • Maintaining audit-ready documentation

For IDS teams, this means that electronic documentation, paired with structured SOPs, can fully meet regulatory expectations for compliance and accuracy.

Operational Benefits for IDS Pharmacies

Remote monitoring delivers meaningful improvements across daily operations, including:

  1. Reduced Staff Burden: Monitoring visits historically consumed hours of staff time. Remote workflows eliminate the need to escort monitors, gather paper files, or prepare physical documentation.
  2. Greater Efficiency and Accuracy: Real-time visibility into accountability logs and inventory reduces transcription errors, missed entries, and delays in issue resolution.
  3. Stronger Audit Readiness: Audit trails, standardized documentation, and centralized review ensure sites are always prepared for inspections, without last-minute document hunts.
  4. Streamlined Supply Management: Digital visibility into stock levels, quarantined items, and returns improves supply forecasting and minimizes risk of stockouts or delays.

Why Remote Monitoring Is Here to Stay

In the past six months alone, nearly 50,000 monitor visits conducted in Vestigo® were remote – representing over 72% of total visits. The industry is clearly moving toward digital-first oversight models that reduce cost, streamline operations, and improve data quality.

For IDS pharmacies, adopting remote monitoring isn’t just a modern convenience; it’s a strategic imperative. It enables teams to work more efficiently, collaborate more effectively, and maintain the high standards required for trial success.

Conclusion

The future of clinical trial monitoring is flexible, digital, and collaborative. Remote monitoring empowers IDS teams with the tools and structure they need to maintain compliance, enhance operational efficiency, and reduce the burden of traditional onsite visits. With strong regulatory support and proven operational benefits, remote monitoring is rapidly becoming the gold standard for pharmacy oversight in clinical research.Aletti, R. (2025, December 19). Redefining readiness: Optimizing pharmacy compliance and operational efficiency with remote monitoring practices. McCreadie Group.

References

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