Regulatory Readiness In Clinical Supply: Building A Culture Of Compliance, Part 1

By Kimberly Chew, senior counsel, Husch Blackwell LLP

Inspection readiness has never been more critical for clinical supply leaders. As the regulatory landscape evolves and FDA oversight intensifies, organizations are expected to demonstrate unwavering compliance, robust data integrity, and seamless investigational product (IP) accountability at every stage of the clinical trial life cycle. The stakes are high: regulatory gaps can lead to costly delays, sanctions, or reputational harm, while strong inspection preparedness protects both patients and organizational success.

Recent headlines reinforce the global importance of robust data integrity and inspection readiness. On January 30, 2026, European regulators announced that it is launching a review of a high-profile medicine after concerns emerged about the handling of pivotal clinical trial data.¹ Since the product was approved in both the U.S. and EU based on these data, this development illustrates how data integrity issues can trigger regulatory scrutiny across multiple jurisdictions. For clinical supply and quality leaders, it is a timely reminder that maintaining rigorous data management and compliance practices are essential, not only to meet FDA expectations but also to ensure global regulatory confidence in IP.

This article is the first in a two-part series providing guidance for clinical supply, operations, and quality professionals on building a culture of compliance. Here, we focus on foundational strategies for integrating compliance and data integrity into daily operations. Part 2 will address practical steps for inspection readiness and adapting to new regulatory expectations.

Integrate Compliance Into Daily Supply Operations

Inspection readiness begins with the integration of compliance into every aspect of daily clinical supply operations. This approach requires ongoing commitment, starting with regular training for supply, operations, and quality personnel on the latest FDA regulations, Good Clinical Practice (GCP) requirements, and any relevant guidance updates.² Training should be thorough and include all critical elements such as IP handling, storage, labeling, and documentation practices.³

It is also essential to carefully document the rationale behind standard operating procedures (SOPs), especially those that address product receipt, storage, temperature excursions, returns, and destruction.⁴ All SOPs and essential supply chain documentation, including inventory logs, temperature monitoring records, chain of custody forms, and deviation reports, should be centralized in a secure and easily accessible system. Effective data management is equally important, ensuring that both electronic and paper records can be efficiently retrieved and that all electronic systems comply with 21 CFR Part 11 requirements for electronic signatures and data integrity. By embedding these practices into daily operations, organizations foster a culture of continuous compliance that is critical for audit preparedness.

Safeguard Data Integrity And Investigational Product Accountability

Safeguarding data integrity and ensuring investigational IP accountability are fundamental expectations of the FDA, with even greater scrutiny applied to controlled substances. To meet these standards, every IP transaction, including receipt, dispensing, return, destruction, and reconciliation, must be promptly and accurately documented in compliance with ALCOA principles (attributable, legible, contemporaneous, original, and accurate).⁵ Maintaining a detailed, unbroken chain of custody for all product movements is essential, tracking each step from the manufacturer to the clinical site and ultimately to destruction. Storage conditions, including temperature and humidity, should be meticulously recorded, with real-time monitoring and alert systems in place to capture and respond to any excursions.⁶ All electronic systems used for documentation should meet regulatory requirements for secure audit trails, restricted access, and robust data retention.⁷

The risks of inadequate accountability can be seen in a scenario where a DEA-scheduled investigational drug goes missing due to a lack of clear SOPs and designated custodianship. For example, a situation in which a controlled substance is delivered to a loading dock but is not properly tracked or assigned to a responsible individual results in the product being misplaced for several months. If the drug is a controlled substance, the organization would be required to report the loss to the DEA — even if the loss is only temporary — a step that could increase the likelihood of a regulatory inspection and potentially jeopardize the entity’s registration status. This example underscores the critical importance of governing every handoff with clear SOPs, assigning specific personnel to each step, and regularly auditing procedures to ensure continuous compliance and accountability, especially when dealing with controlled substances.

Conclusion:

Embedding compliance and data integrity into daily clinical supply operations is the foundation of regulatory readiness. By maintaining robust SOPs, thorough documentation, and clear accountability, organizations can reduce risk and strengthen the reliability of their investigational product management. These practices not only support successful FDA inspections but also cultivate a culture of continuous compliance that reinforces quality across all aspects of clinical supply operations.

In Part 2 of this series, we will explore practical steps clinical supply leaders can take to prepare for and manage FDA inspections with confidence. This includes building readiness among staff and vendors, conducting internal audits and mock inspections, and understanding the expectations for both traditional on-site inspections and the FDA’s newer remote regulatory assessments. We will also cover best practices for managing the inspection process itself, from engaging with inspectors to documenting responses and addressing observations, as well as using inspection outcomes to drive ongoing process improvements. By linking these proactive strategies to the foundational compliance practices described here, clinical supply leaders can ensure their teams are prepared for any regulatory challenge and positioned to demonstrate consistent quality and accountability.

References

About The Author:

Kimberly Chew is senior counsel at Husch Blackwell LLP’s virtual office, The Link. With a robust background in biotech research, she guides clients through the complexities of clinical trials, FDA regulations, and academic research compliance. As cofounder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group, Kimberly is passionate about advancing psychedelic therapeutics for mental health. Her practice also includes regulatory due diligence and intellectual property enforcement, with a particular focus on patent infringement and validity. She can be reached at kimberly.chew@huschblackwell.com.