Building A Culture Of Compliance In Clinical Supply

By Julie David, Content Lead – Trade Compliance Academy

Clinical supply organizations operate in one of the most highly regulated environments in the world. Ensuring that investigational products, biologics, and related materials move efficiently to clinical sites across the globe requires not only operational excellence but also compliance with complex regulatory requirements. Among these, U.S. export controls pose unique challenges because they govern how controlled items, technology, and data are shared across borders, even with non-U.S. persons within the United States.

Export controls are administered primarily under the Export Administration Regulations (EAR) by the U.S. Department of Commerce’s Bureau of Industry and Security (BIS), aimed at protecting national security and foreign policy interests and preventing diversion of sensitive items.

A robust compliance culture that emphasizes training, clear processes, and shared accountability is essential. Below, we explore actionable steps clinical supply teams and their partners can take to build and sustain that culture, with practical tools to align behavior and operations with export control regulations.

Why A Culture Of Compliance Matters In Clinical Supply

Human error and process gaps are among the leading drivers of regulatory violations. In clinical supply environments, noncompliance with export controls can result in penalties, delays in study execution, reputational harm, and even restrictions on future business or research activity. Moreover, export regulations define “export” broadly, covering the transfer of items and information to foreign nationals inside and outside the United States, making compliance everyone’s responsibility.

A compliance culture integrates regulatory priorities into everyday practice. Rather than treating compliance as an afterthought or a purely legal function, organizations should embed it into training curricula, SOPs, performance metrics, and partner expectations.

Start With Leadership Commitment And Clear Policies

Strong compliance begins at the top. Senior leadership needs to publicly champion compliance initiatives, allocate sufficient resources, and visibly support training and enforcement mechanisms. This includes:

• establishing an export compliance program (ECP) that outlines roles, responsibilities, and escalation paths
• resourcing compliance functions with training personnel, tools (such as restricted party screening and classification software), and periodic external support when needed
• communicating expectations clearly across departments and with external partners.

The BIS export compliance guidelines emphasize that effective compliance programs start with management commitment and risk assessment frameworks.

Best Practice Tip: Embed export compliance language into corporate governance documents and internal policies to ensure visibility and accountability from the boardroom to the warehouse.

Conduct Risk Assessments And Gap Analyses

Before designing training or processes, you need to understand WHERE risks exist. A risk assessment should:

• identify which items, data, and technologies fall under export control jurisdiction
• determine where export activities occur, including international shipping, data sharing, and collaboration with foreign nationals
• assess partners, customers, and vendors for potential sanctions or restrictions
• evaluate historical compliance gaps and audit findings.

This risk-based approach allows compliance teams to prioritize training and controls where they are most needed. By systematically asking the right questions, such as whether a product is controlled, whether a transaction involves a restricted party, or if a license is required, teams can anticipate challenges before they become compliance issues.

Implementation Tip: Use a documented and repeatable process, updated at a minimum annually and with regulatory changes, to keep risk assessments current.

Design Practical, Tiered Training Programs

One of the most impactful ways to build a compliance culture is through training that is regular, relevant, and role-based. Export controls affect many functions in clinical supply, including supply planning, packaging, logistics, quality, regulatory affairs, and third-party partners.

Training should:

• introduce foundational concepts such as what constitutes an “export,” definitions of EAR, BIS roles, how to identify red flags, and consequences of noncompliance
• provide role-specific instruction on procedures such as classifying items, screening parties, and interpreting license requirements
• include real-world scenarios drawn from the organization’s operations, helping learners apply abstract rules to concrete tasks
• be repeated and updated as regulations or internal processes evolve. Training is not a one-and-done exercise and should be refreshed annually or as the regulations change.

BIS guidance highlights that training should extend beyond basic compliance awareness to include detailed instruction for those with export responsibilities.

Training Metrics: Track who completed training, assessment scores, and whether learners demonstrate compliance concepts in practice. Tie training completion to performance goals where appropriate.

Embed Compliance Into Supply Chain Processes And Standards

Training must be reinforced by clear, accessible processes. Teams should codify SOPs that:

• define how to classify items for export control purposes
• outline procedures for screening customers, sites, and partners against government lists
• describe how to document and retain compliance records, as required under EAR §762
• clarify milestone-based compliance checks before packaging, transport, or technology transfer.

Incorporate compliance checkpoints into existing workflows (e.g., release criteria before shipment, contract review before partner onboarding) to make compliance a natural part of execution.

Partner Integration: Extend these expectations to third parties through contractual language and shared SOPs to ensure alignment across the network.

Leverage Technology For Screening And Monitoring

Automation tools can substantially elevate compliance effectiveness. Solutions that provide real-time screening against consolidated government lists can help teams catch issues early.

Technology can also:

• flag potential restricted party connections
• maintain records of export control classifications and licenses
• trigger alerts when regulatory changes might impact ongoing activities.

These tools reduce reliance on manual checks and support compliance officers in managing risk at scale.

Audit, Correct, And Continuous Improvement

An effective compliance culture is dynamic. Regular internal audits and periodic independent reviews help organizations verify that policies and training translate into compliance behavior. Identifying gaps allows teams to renew training, revise processes, and refine controls.

Strong programs also define how to respond to compliance violations, whether minor procedural errors or potential export violations. Having clear corrective action plans ensures transparency and reinforces a culture where individuals report issues without fear of punitive reprisal.

BIS guidance calls for regular auditing and corrective actions as essential elements of a sustained compliance program.

Bringing It All Together: Shared Accountability And Sustainable Compliance

Export control compliance in clinical supply is not a checkbox; it is a strategic enabler that protects patient safety, preserves access to global markets, and mitigates operational risk. By investing in leadership commitment, structured risk assessment, tiered training, embedded processes, and technology solutions, organizations can foster a culture where compliance is second nature.

Adopting these approaches equips teams and partners not only to follow current regulations but to adapt confidently as regulatory landscapes evolve. This culture of compliance becomes a competitive differentiator, one that supports both efficient clinical supply operations and long-term business sustainability.

About the Author:

Julie David is the Content Lead for the Trade Compliance Academy at Skill Dynamics, where she creates and maintains training programs that help organizations embed trade compliance directly into their business processes. With more than 14 years of experience in U.S. export controls, regulatory compliance, and corporate fraud detection and prevention, Julie brings a strong risk-management lens to building effective compliance programs. Her work focuses on fostering compliance cultures, strengthening internal controls, and equipping teams with the knowledge they need to proactively identify risk, prevent violations, and support business objectives. Through Skill Dynamics’ role-based learning platform, Julie ensures trade compliance training is practical, engaging, and aligned with how businesses actually operate.