How Can Proactive Compliance Transform Quality in Clinical Trials?

How Can Proactive Compliance Transform Quality in Clinical Trials?

In the dynamic landscape of clinical trials, ensuring compliance and maintaining high-quality standards are paramount.

The field of quality and compliance in clinical trials is undergoing significant transformations driven by technological advancements, regulatory changes and evolving industry practices. These changes aim to enhance efficiency, ensure patient safety and improve the reliability of trial outcomes.

Steve Begley, Chief Compliance Officer, YPrime

Xtalks recently spoke with Steve Begley, Chief Compliance Officer at YPrime, to discuss his innovative approach to quality management and compliance.

Steve’s proactive strategy contrasts with traditional reactive methods, offering valuable insights for organizations aiming to enhance their quality processes.



Improving Efficiencies through Proactive Compliance

When asked about the inspiration behind his proactive approach, Steve explained, “Seeing smaller items that occurred randomly made it feel almost as if we were playing a game of whack-a-mole. That didn’t really seem efficient.”

Rather than addressing issues as they arise, Steve’s team decided to forecast potential problems based on their knowledge and experiences. This shift allowed them to identify and document potential problem areas, assign responsibilities, track progress through dashboards and hold regular follow-up meetings. By anticipating issues, they could address them before they escalated, ensuring smoother project execution.

In an industry where delays can be costly and jeopardize patient safety, Steve’s team has achieved the impressive feat of consistently closing CAPA (corrective and preventive actions) investigations within 30 days. The key, according to Steve, lies in their automated dashboard, which tracks all CAPAs and their statuses.

This transparency enables internal owners to monitor progress and seek support as needed. Weekly executive reviews and daily standup meetings ensure that everyone is aligned, and any obstacles are promptly addressed. This systematic approach not only resolves issues quickly but also instills confidence in sponsors, vendors and patients alike.

Leveraging Data-Driven Insights

Data-driven insights play a crucial role in proactive compliance strategies for continuous improvement. Steve explains that YPrime employs an internal AI team and a quality systems and analytics group to analyze project data and predict potential scenarios based on past performance.

“We want sponsors to see us as partners, providing actionable insights in real-time,” Steve emphasized. By using QMS (Quality Management System) data, they can forecast future CAPAs and proactively implement mitigations. This forward-thinking approach allows them to prevent issues before they arise, ensuring a higher level of quality and reliability.

Proactive Compliance Leadership

As a mentor and leader, Steve is committed to shaping the next generation of quality leaders. He stresses the importance of proactivity and the impact the field has on people’s lives. By emphasizing the human aspect of the work, he hopes to inspire a legacy of proactive compliance.

“Because the criticality of our services is attached to people’s well-being and their lives, we want to make certain that they understand. It could be their parents, their children, extended family members, friends, colleagues or neighbors, or it could be them at some point in the future who need access to these very life-saving drugs that we are helping to bring to market with our technologies.”

“Our next generation of quality is with us today, getting real-world exposure to using analytics and learning about the benefits of proactivity,” Steve says. He encourages a commitment to excellence and a deep understanding of the significance of the role of quality and compliance leadership in the industry.

For organizations looking to adopt a proactive approach to quality and clinical trials, Steve offers some valuable advice:

  • Hire for fit and talent: Ensure that hires not only have the necessary skills but also fit well within the organizational culture.
  • Cultivate continuous learning: Foster an environment where new ideas and learnings are shared and discussed across the organization.
  • Connect and learn: Engage with others in the industry to learn from their experiences and integrate those insights into your processes.
  • Share progress and aspirations: Regularly update the team on progress and goals, and ensure visible support from leadership to maintain enthusiasm and commitment.
  • Define and achieve success together: Collaboratively define success and hold everyone accountable for achieving it, recognizing that it requires a collective effort. It takes a village, and everyone should be moving in concert with each other.

Steve’s proactive approach to quality management not only sets a new standard in the industry but also provides a roadmap for others to follow. By anticipating problems, leveraging data and fostering a culture of continuous improvement, organizations can achieve higher standards of quality and reliability in clinical trials.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.

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