Don’t Let Tech Betray Your Trial: The Urgent Need for Vigilant Third-Party Management

Imagine yourself at your doctor’s office, rolling up your sleeve for your annual flu shot. You trust that what’s about to go into your arm is safe and effective. But what if the clinical trial data behind that vaccine was tainted—by a malfunctioning digital system, a flawed randomization process, or a tech vendor that cut corners? Would you still feel comfortable getting that shot? 

This is not just hypothetical. As clinical trials ride the wave of technological innovation, AI-driven Interactive Response Technology (IRT) systems and advanced cloud platforms are transforming how we design, run, and monitor studies. These tools promise efficiency, scalability, and real-time insights, but they also demand heightened vigilance to ensure data remains accurate, secure, and compliant. 

The Two Sides of AI-Driven IRT and Cloud Platforms 

IRT systems are specialized digital platforms that automate essential clinical trial functions such as patient randomization, drug supply management, and real-time tracking across global sites. When integrated with Electronic Data Capture (EDC) and other eClinical systems—and, increasingly, enhanced by AI—these platforms help reduce manual errors, streamline logistics, and enable adaptive, data-driven trial designs. Ongoing advancements are making clinical trials even smarter, with solutions for improved patient recruitment and randomization, real-time monitoring and predictive analytics, automated data cleaning and standardization, and optimized resource allocation. Cloud-based IRT further extends these benefits by supporting decentralized and even home-based trials, giving sponsors and investigators instant access to data worldwide. 

Yet, despite the buzz, there’s a risk that the basics—data integrity [1,2], validation, and robust oversight [3]—get overshadowed. AI algorithms and digital platforms, if not properly validated or integrated, can introduce errors that lead to data discrepancies, unintended unblinding, or regulatory non-compliance. The complexity of these interconnected systems means even small oversights can have outsized consequences for data integrity and patient safety. As we embrace the promise of new tech, we must not lose sight of the foundational need for rigorous oversight and data stewardship. 

What Happens When Things Go Wrong? Real-World Lessons 

      1. When IRT Goes Off Script —The Acelyrin–Fortrea Case 

In September 2023, Acelyrin’s lead drug candidate, izokibep, failed a pivotal phase 2b/3 trial—sending shockwaves through the biotech sector [4]. At first, it looked like a classic case of drug inefficacy. But the real culprit? A programming error by their contract research organization (CRO), Fortrea. A vendor mis-programmed the dosing sequence in a psoriatic arthritis trial, so patients received treatments in the wrong order. This critical error slipped through the CRO’s internal checks and only surfaced after the trial’s disappointing outcome. 

Key Lessons: 

• Vendor Oversight Is Essential—and if you’re operating in the EU, it’s a regulatory must. Even seasoned CROs and vendors can make mistakes with far-reaching consequences. From a regulatory standpoint, sponsors are ultimately responsible for ensuring rigorous oversight of all CROs, vendors, including conducting regular audits and maintaining transparent communication to catch issues early. 

• Protect Data Integrity Proactively. Whether it’s a traditional or an AI-driven system, programming errors can compromise trial validity. Automated systems are only as reliable as the underlying processes and people managing them. 

• Independent Verification Matters. Third-party auditors can uncover hidden issues and restore confidence in trial data—especially as AI and automation add new layers of complexity. 

     2. When Cloud Turns Cloudy —The Applied Therapeutics Example 

In December 2024, The FDA issued a warning letter to Applied Therapeutics, Inc. after a pre-approval inspection of its pivotal pediatric rare disease trial [5]. Here’s what went wrong: at least 19 patients received lower-than-protocol doses due to mislabeled investigational product. Worse, the company reported intended doses instead of what was actually administered—and failed to clearly explain or analyze the errors. To top it off, a third-party vendor deleted key electronic clinical trial data and audit trails just before the FDA inspection, resulting in permanent data loss. The fallout? A Complete Response Letter (CRL), regulatory scrutiny, and shareholder lawsuits. 

Key Lessons: 

• Never Assume Vendor Systems Are Secure. Sponsors must verify that third-party vendors have strong data protection and backup measures in place—especially for electronic systems—since data loss or unauthorized deletions by vendors can have irreversible consequences for trial integrity and regulatory approval. 

• Validate Every System. Complete audit trails and audit trail reviews, and robust validation are non-negotiable for any digital system managing trial data. This guarantees data integrity and helps detect issues before they impact trial outcomes or regulatory compliance. 

• Data Loss Destroys Trust. Losing essential data and lacking transparency not only invite regulatory penalties and risk invalidating trial results, but also seriously undermine the confidence of regulators, stakeholders, and the public in the entire research process. 

Action Items for Sponsors and Stakeholders 

The rise of AI-driven IRT and advanced cloud technologies is transforming clinical trials, offering greater speed, flexibility, and new capabilities. But these advances also introduce new risks and complexities in third-party management. To maintain data integrity: 

• Thoroughly vet and validate all qualified tech-vendors, including those providing AI and cloud solutions. 

• Define explicit contractual requirements for data governance, auditability, and incident management. 

• Maintain continuous oversight with regular audits, performance reviews, and independent verification. 

• Prioritize transparency, explainability, and regulatory compliance in every technology deployment. 

In this new era, technological innovation and third-party management must go hand in hand. Reliable and successful clinical trials are possible only when sponsors integrate breakthrough solutions with rigorous oversight. 

Don’t let tech betray your trial! Contact us today for expert advice on how to ensure your data integrity and third-party oversight in the digital age.  

1. Data Integrity Challenges in the Scope of Clinical Trials (Part 1) https://www.gxp-cc.com/insights/blog/data-integrity-challenges-in-the-scope-of-clinical-trials-part-1/ 
2. Data Integrity Challenges in the Scope of Clinical Trials (Part 2) https://www.gxp-cc.com/insights/blog/data-integrity-challenges-in-the-scope-of-clinical-trials-part-2/ 
3. Sponsor Oversight: Legal Responsibility and Industry Best Practice https://www.gxp-cc.com/insights/blog/sponsor-oversight-legal-responsibility-and-industry-best-practice/  
4. https://www.fiercebiotech.com/biotech/acelyrin-blames-cro-error-shocking-phase-3-failure-sent-shiver-through-biotech-ipo-market 
5. FDA Warning Letter to Applied Therapeutics, Inc., December 2024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/applied-therapeutics-inc-696833-12032024