Beyond the Checkbox: The Hidden Risks in Clinical System Compliance

Sponsors Are Still Getting This Wrong - Regulators Are Noticing

2025 seems to be flying by. Between client work, appearing on webinars like this one, and navigating the evolving regulatory landscape, I've also been writing a whitepaper on a topic that sponsors can no longer afford to ignore: clinical system compliance. 

Why? Because despite all the regulatory guidance, sponsors are still making the same mistakes. And regulators are no longer overlooking them. 

The compliance landscape has shifted. Regulatory agencies have raised the bar, and sponsors are now being held directly accountable for clinical systems and data integrity oversight. The days of assuming vendors or CROs have it under control are over. 

I've seen first-hand how sponsors are falling short—not intentionally, but because the expectations have changed faster than many realise. If you're working in clinical systems, digital operations, or vendor oversight, this needs to be on your radar. 

The Industry's Wake-Up Call 

For years, many sponsors have treated clinical system compliance as a vendor problem—assuming that, if they hired the right providers, everything would be handled correctly. That is no longer the case. 

Regulators have shifted from trusting vendor assurances to demanding proof of sponsor-driven oversight. And many biotechs are completely unprepared for that change. 

Look at recent FDA inspections—sponsors are receiving findings for: 

• Failing to validate their computerized systems properly 

• Not demonstrating direct oversight of vendor-managed data 

• Lacking audit-ready documentation for critical systems 

These are not minor administrative oversights—they are fundamental issues that can derail a trial. 

 Yet, I still hear sponsors say: 

• "Our CRO manages the systems." 

• "Our vendor validates their system; we don't have to be involved." 

• "We selected our technology vendor; isn't that enough?" 

 No. It isn't. 

The Compliance Gaps That Could Cost Your Trial 

Too many sponsors are underestimating what regulators expect from them. 

The most common failures I see include: 

• Assuming vendor validation is sufficient. Vendors may validate their systems, but that does not mean they are validated for your specific trial. Sponsors must take a risk-based approach to providing oversight on the validation process and documentation, and for some systems, have an active role in UAT. 

• Mistaking a data flow diagram for compliance. Mapping data flow is useful, but it does not confirm that the systems processing that data are secure, validated, and compliant. Sponsors need to demonstrate risk mitigation, not just documentation. And in many of these cases, what I review is often an operational data flow diagram rather than an electronic data flow diagram, which means critical system information is missing.  

• Relying entirely on the CRO. A CRO can execute delegated tasks, but they cannot take on a sponsor's regulatory obligations. Final responsibility always rests with the sponsor, including data integrity. 

These assumptions do not hold up under regulatory scrutiny. Sponsors have already faced regulatory warnings, rejected trial data, and costly delays for failing to demonstrate proper oversight. 

What's at Stake? 

If clinical systems compliance isn't handled correctly, the risks are significant: 

• Regulatory warnings and findings that could delay or derail approvals. 

• Trial data is deemed unreliable, forcing sponsors to repeat studies or, in worst-case scenarios, making the data unusable. 

• Investor confidence being damaged—if regulators raise questions about compliance, it impacts credibility, valuation, and future funding. 

This is already happening. Regulators have flagged data integrity concerns in recent inspections, and sponsors are now facing the consequences. 

Why This Whitepaper? Why Now? 

 Mainly because I keep seeing the same issues over and over again. Sponsors are underprepared for inspections, over-reliant on vendors, and often unaware of how serious the regulatory shift has been. 

 The biotech industry has reached a turning point—and sponsors who fail to act now will find themselves caught off guard when regulators come knocking. 

If you work in clinical operations or vendor oversight, you need to be asking: 

• Do we have clear oversight of all computerized systems used in our trials? 

• Have we independently verified our vendors' validation processes and validation documentation? 

• Can we demonstrate compliance in an audit, or would we be scrambling? 

 If the answers aren't clear, this whitepaper is for you. 

What This Whitepaper Covers—And Why You Need to Read It 

This isn't just another compliance discussion. This is a practical guide to understanding: 

• The biggest compliance failures are happening right now—and why sponsors keep making them. 

• How regulatory expectations have shifted—and what you must do to stay ahead. 

• A step-by-step framework for taking ownership of clinical system oversight. 

• A real case study of what happens when sponsors fail to act—and how it could have been avoided. 

 The regulatory landscape has changed. Have you? Sponsors who ignore these risks are already facing consequences. Don't wait until an inspection exposes them. 

[Download the whitepaper now]