White Paper: Protecting Your Clinical Trial from Hidden Compliance Risks
Why vendor assurances aren’t enough—and what you must do to safeguard data integrity
Vendor compliance doesn’t guarantee your trial’s success. Sponsors are ultimately responsible for validation, data integrity, and regulatory adherence.
This whitepaper uncovers the hidden risks in clinical systems compliance and provides actionable steps to ensure oversight and audit readiness. Download it now and take control of your clinical trial’s compliance strategy.
About the white paper
Regulatory bodies are intensifying their focus on data integrity and computerized system validation, yet many sponsors still rely on incomplete or vendor-dependent compliance strategies. An electronic data flow diagram is only the first step – without deeper oversight, sponsors risk regulatory findings, trial delays, and data integrity failures.
Authored by Lauren Alani, Director of Digital Innovation at Seuss+, this white paper explores:
- The hidden risks sponsors face when assuming vendors have compliance and validation covered
- Key steps sponsors must take to safeguard the data integrity of their trial
- An example of an FDA warning letter sent to a Sponsor, focusing on data integrity failures, highlighting the growing regulatory focus
- A case study on challenges a sponsor faced and how to prevent similar pitfalls for your own clinical trials
- Practical strategies that should be implemented to reduce risk, take advantage of opportunities and to strengthen compliance following a Clinical Systems Analysis (CSA)
Why This Matters for Biotechs
Recent FDA warning letters highlight that data integrity failures can result in trial disruptions, regulatory rejection, and reputational damage. Sponsors must take ownership of their clinical data and system validation—failure to do so puts trial outcomes at risk.
Download the Mini White Paper Now to learn how Clinical Systems Analysis (CSA) can help you proactively mitigate risks and strengthen your clinical trial compliance.
About Seuss+
Founded in 2012 by CEOs Sabine Hutchison and Kieran Canisius, Seuss+ is the go-to expert in vendor optimization for clinical development within the biotech and pharmaceutical industries. We work closely with sponsors to ensure that vendor relationships are optimized, allowing clinical trials to progress smoothly and efficiently. Our services, which include Vendor Strategy, Market Scans, Contract Negotiation, and Vendor Management, are designed to help sponsors achieve their milestones with clarity and confidence, driving success in clinical development.
Lauren Alani,
Director of Digital Innovation, Seuss+
About the Author
Lauren Alani is the Director of Digital Innovation at Seuss+, where she specializes in integrating emerging technologies into clinical development strategies. With deep expertise in clinical systems validation, regulatory technology, and digital oversight, Lauren works closely with biotech and pharmaceutical sponsors to enhance data integrity, compliance, and operational efficiency.
Her focus is on clinical technology assessment, vendor compliance, and process optimization, ensuring that sponsors meet evolving regulatory expectations, including FDA 21 CFR Part 11, ICH GCP, EMA, and MHRA data integrity requirements. At Seuss+, she leads Clinical Systems Analysis (CSA) initiatives, helping sponsors identify risks, gain control of the computerized systems delivering critical trial data, and improve the likelihood of clinical trial success.
Lauren is committed to modernizing clinical operations and supporting sponsors in navigating regulatory complexities through innovative, scalable solutions that strengthen compliance and data integrity.
Download it now and take the next step in mastering vendor selection for your biotech’s success.
Frequently Asked Questions
Who should read this whitepaper?
This white paper is essential for biotech and pharmaceutical sponsors, clinical operations leaders, and compliance professionals who need to ensure regulatory adherence and data integrity in their trials.
What will I learn from this white paper?
You’ll gain insights into the hidden risks in clinical systems compliance, the limitations of vendor assurances, and the steps you must take to validate and oversee your trial’s technology and data flow.
Why is vendor compliance not enough?
Regulatory bodies hold sponsors accountable for data integrity, meaning you can’t solely rely on vendors for compliance. This whitepaper explains why sponsors must actively validate their systems and maintain oversight.
How can this white paper help improve my clinical trial operations?
It provides practical guidance on assessing risks, implementing oversight measures, and ensuring regulatory compliance – helping you avoid costly delays, regulatory findings, and compromised data integrity.
How do I get the white paper?
Simply fill out the form on this page, and you’ll receive instant access to download the white paper.
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