Key Takeaways from the Inaugural Beyond Clinical Compliance Conference
I recently attended the Beyond Clinical Compliance conference in Philadelphia, hosted by KH Conferences. The presentations and conversations offered clear insight into where the industry is headed, especially around ICH E6(R3) adoption, risk management, data integrity, quality culture, and GCP inspection readiness.
ICH E6(R3)
The industry is steadily moving toward adoption of ICH E6 R3. While this release does not fundamentally change the principles of R2, it clarifies expectations and provides more detailed guidance to help sponsors strengthen compliance and GCP inspection readiness. Key themes include several areas critical to ICH E6(R3) compliance and GCP inspection readiness:
- Data Integrity: R3 requires sponsors to demonstrate full control of trial data and digital systems throughout the lifecycle. This means aligning systems validation and processes to ensure traceability and compliance.
- Trial Oversight: The focus shifts from reactive to risk-proportionate quality by design, supported by continuous monitoring, feedback, and improvement loops.
- Risk Management: Regulators expect a documented risk framework with logs, reviews, and remediation evidence from the start of the trial—not midstream.
- Gap Assessments: Organizations should conduct SOP and process gap assessments to align with R3 expectations.
Risk Management
Risk management must be built in from the start of study design. Preparing for a GCP inspection cannot wait until a trial is already underway.
- The danger of operating in “firefighting” mode was highlighted. Instead, teams should work cross-functionally, communicate early and often, and ensure risks are understood and acted upon before they escalate.
- Quality and risk management are inseparable. Inspectors often request documents like the risk register upfront. A strong, well-documented framework with logs, reviews, and remediation evidence is central to ICH E6(R3) compliance and GCP inspection readiness.
Building Quality into Culture
Clinical quality must have a seat at the table to drive success—even when it feels like there are too many “tables” to navigate.
- Culture matters: teams collaborate best when quality professionals adapt their language to their audience and provide context for why certain processes or exercises are necessary.
- Stronger teams enable streamlined processes, but training and monitoring remain vital. Interactive, scenario-based based training often proves more effective than passive reading—making the difference between basic compliance and true organizational quality.
Closing Thoughts
The conference reinforced a clear message: success under ICH E6(R3) is not about reacting to inspections. It requires embedding quality and risk management into every layer of a trial. Data integrity, proactive oversight, and a strong quality culture are no longer optional—they are essential.
As organizations prepare for R3, the real differentiator will be how effectively they integrate these principles into daily operations, ensuring both compliance and confidence in inspection readiness.
Contributed by Kathleen Mellet, Business Analyst, Just in Time GCP
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