Quality by Design - Not Inspection

“Quality should never be reactive - it must be intentionally built into every process. Strengthening our QMS ensures we maintain the oversight, consistency, and accountability that sponsors expect.”

- Trish Schaefer, Senior Director of Quality Assurance, OWL Oncology 

How OWL Oncology Research Is Strengthening Its Quality Management System

At OWL Oncology Research, quality and regulatory compliance remain foundational to how we support sponsors, partners, and patients. As regulatory expectations evolve and clinical trials grow more complex, we continue to invest in systems and processes that keep our work modern, compliant, and inspection ready.

We are proud to share important advancements to our Quality Management System (QMS) - designed to strengthen oversight, improve consistency, and support operational excellence across every engagement.

Updated SOPs Aligned with Modern Regulatory Expectations

Our Quality Assurance experts are updating and expanding our Standard Operating Procedures (SOPs) to more explicitly align with the latest regulatory guidance, including ICH E6(R3) and international standards.

These updates ensure that when you partner with OWL, you are operating within a framework that is:

• Modern and globally aligned

• Built to withstand regulatory scrutiny

• Designed to support efficient, high-quality execution

  
  

OWL’s updated quality framework promotes alignment across teams, helping ensure studies remain consistently inspection-ready.

Enhanced Oversight Through DOT Compliance eQMS

To further advance our quality infrastructure, OWL is implementing DOT Compliance electronic Quality Management System (eQMS) - a cloud-based software platform that centralizes quality processes for life sciences organizations.

This transition will enhance:

• Training compliance

• Documentation control

• Process visibility

• Audit readiness

• Traceable tracking of quality processes from initiation through closure

DOT Compliance supports:

• 21 CFR Part 11

• EU Annex 11

• Relevant ISO standards

Ultimately, sponsors benefit from more consistent operations, faster turnaround times, and greater confidence in execution.

What This Means for Our Partners

As these updates roll out, partners can expect:

• Streamlined SOP training and tracking for OWL team members to ensure consistent implementation

• Role-specific guidance of OWL policies

• Clear communication around timing and next steps

Our goal is simple: make quality seamless, transparent, and reliable for every organization we support.

Looking Ahead

These enhancements reflect OWL’s continued commitment to raising the standard for quality in clinical research - taking a proactive approach so our partners can move forward with clarity and confidence.

After all, strong studies require both sharp vision and disciplined execution - and we believe quality should guide every step of the flight.