This Blog Post Series – Summarising Recent Conference Themes
Over the past few months, I’ve had the privilege of participating in several key industry events, including RQA 2024 in Brighton and COG Europe in Amsterdam. Through presentations, panel discussions, and countless conversations with industry colleagues, several crucial themes have emerged that I believe warrant deeper exploration.
This post is the first in a four-part series examining the critical challenges and opportunities facing our industry. Over the coming weeks, I’ll be sharing insights on:
- Modernising Service Provider Management: Your Current Approach May Be Obsolete
- Key Trends Shaping Clinical Trial Quality in 2024
- Vendor Risk Management: A Modern Approach to Clinical Trial Success
- The Human Side of Clinical Trial Quality
Each piece draws from real conversations, shared challenges, and innovative solutions I’ve encountered during these events. The series aims to not just highlight issues, but to offer practical approaches for moving forward in an increasingly complex clinical trial landscape.
The Changing Landscape of Clinical Trial Partnerships
If you’re responsible for clinical trial operations, you’ve likely noticed the shifting landscape of vendor relationships. The days of simply managing a primary CRO are long gone. Today’s trials involve an intricate web of service providers, each playing a crucial role in your study’s success.
As someone who regularly engages with quality assurance professionals and clinical operations leaders, I’ve witnessed firsthand the growing complexity of these relationships.
A Paradigm Shift in Oversight
Here’s what might surprise you: the traditional CRO-centric oversight model isn’t just outdated—it’s potentially dangerous. The forthcoming ICH E6(R3) guideline doesn’t just suggest a shift in terminology from “CRO” to “service provider” (mentioned 36 times compared to CRO’s previous 9 mentions); it signals a fundamental transformation in how we must approach vendor management.
This isn’t a semantic change—it’s a recognition that every service provider, regardless of size or role, can significantly impact your trial’s quality and risk profile.
Industry Insights From the Front Lines
Consider these compelling facts from recent industry gatherings:
- During the RQA 2024 conference, quality professionals consistently reported struggling with “manual, untidy” oversight processes
- Multiple sessions highlighted how decentralised trials have exponentially increased the number of service providers involved in a single study
- Data integrity concerns now extend beyond traditional clinical data to include AI-driven services and long-term storage solutions
- Regulatory authorities are increasingly focussing on vendor oversight during inspections, with insufficient oversight being a common finding
The Hidden Costs of Outdated Oversight
The consequences of inadequate service provider management are severe and immediate. Imagine discovering during an inspection that your AI-powered data analysis provider has been using unvalidated algorithms, or that your remote monitoring vendor’s security protocols don’t meet regulatory requirements.
These aren’t hypothetical scenarios—they’re real situations that can lead to:
- Rejected submissions
- Compromised patient safety
- Lost study data
- Regulatory findings
- Damaged reputation
- Wasted resources and time
Building a Modern Oversight Framework
The path forward lies in adopting a comprehensive, risk-based approach to service provider management that:
- Accurately categorises and prioritises service providers based on risk impact
- Implements proportionate oversight measures
- Maintains real-time visibility of oversight activities across teams
- Ensures consistent documentation of oversight activities
- Facilitates proactive risk identification and mitigation
Measuring Success in the New Era
Effective service provider management can transform your clinical operations:
- Reduce oversight-related findings
- Save time currently spent on manual oversight activities
- Improve first-time inspection success rates
- Enhance collaboration between internal teams and external providers
- Enable rapid response to emerging risks
- Ensure compliance with evolving regulatory requirements
The shift from CRO management to comprehensive service provider oversight isn’t just a regulatory requirement—it’s a strategic imperative.
Those who adapt now will be better positioned to run efficient, compliant, and successful clinical trials in an increasingly complex environment.
Taking the Next Step
As clinical trials become more complex and regulatory scrutiny intensifies, spreadsheets and manual processes are no longer sufficient for managing service provider oversight.
Purpose-built solutions like Mayet offer a streamlined approach to these challenges, providing real-time visibility, automated risk monitoring, and comprehensive oversight documentation in one unified platform.
Want to see how modern vendor management can transform your clinical operations? Book a demonstration with Mayet to discover how our purpose-built solution can help you implement effective oversight processes that meet tomorrow’s challenges today.
Stay tuned for the next post in this series, where we’ll explore the key trends shaping clinical trial quality in 2024, including AI regulation, regulatory divergence, and data integrity challenges.
