From Outsourcing to In-House Excellence
How Aurion Biotech Transformed Clinical Operations with studyOS
Executive Summary
When Aurion Biotech made the bold decision to abandon traditional contract research organization (CRO) partnerships in favor of building internal capabilities, they defied industry conventions. This strategic shift required finding the right technology partner to manage the inherent complexities of in-sourcing clinical operations, monitoring, and data management—all while maintaining the seamless efficiency of their previous CRO relationships.
Through their partnership with studyOS, Aurion proved that lean in-house teams equipped with the right technology platform can not only match but exceed the capabilities of established CROs.
Measurable Results
The Challenge: Maximizing Impact with Minimal Resources
Aurion Biotech is developing AURN001, an investigational single-administration allogeneic cell therapy. Their Phase I/II clinical trial (CLARA) presented significant operational challenges: enrolling 100 subjects across 15 sites over 18 months while maintaining rigorous safety standards and managing the complex manufacturing and dosing logistics of their investigational product.
Operational Bottlenecks
The lean team faced multiple critical demands:
- Ensuring only qualified subjects were enrolled and safely monitored
- Overseeing the intricate manufacturing and dosing processes
- Maintaining rapid execution timelines
Data Management Challenges
Beyond operational demands, Aurion's team struggled with fragmented data management. They spent considerable time manually exporting and consolidating critical data from multiple sources: their electronic data capture (EDC) system, central lab vendor, and imaging vendor. Leadership's directive of "the fewer clicks the better" highlighted how these multi-step processes were hampering efficiency when speed was essential.
The studyOS Solution: Technology Meets Strategy
studyOS transformed Aurion's approach from reactive data management to proactive oversight. Rather than hiring expensive biostatisticians for custom reporting, the platform provided immediate access to comprehensive data visibility. Implementation was completed within four weeks, with studyOS automatically integrating all study data and the team fully trained and operational.
Key Capabilities Delivered
Data Centralization
All data from EDC systems, central lab vendors, and imaging vendors consolidated into a single, accessible platform.
Automatic Vendor Reconciliation
Seamless reconciliation between different vendors, eliminating manual cross-checks.
Advanced Signal Detection
Sophisticated automated alerts for prohibited medications, endpoint thresholds, and missing data.
Team Feedback: The Human Impact
"Using studyOS saves me about 1.5 hours each day because everything I need is right there."
— Aurion Biotech Team Member
"studyOS provides valuable information by adding context to the data, drawing comparisons between timepoints, and identifying issues based on the study protocol."
— Aurion Biotech Team Member
"Had I had to go into EDC, I think it would have taken me triple the amount of time."
— Aurion Biotech Team Member
Clinical Excellence: Recognition and Results
Industry Recognition
In March 2025, Aurion earned the #4 position on Fast Company's Most Innovative Companies list in the Medicines, Therapeutics, and Pharmaceuticals category.
Clinical Trial Success
Over 18 months, Aurion successfully:
- Enrolled and dosed 97 subjects in their North American Phase 1/2 CLARA trial
- Dosed 25 subjects in their Apaneca clinical trial
- Received FDA Breakthrough Therapy Designation
- Obtained Regenerative Medicines Advanced Therapy designation
Conclusion: Redefining Clinical Operations
The Aurion Biotech and studyOS partnership demonstrates that the right technology can enable lean internal teams to achieve oversight and efficiency that rivals—and often exceeds—traditional CRO services. By providing sophisticated monitoring capabilities that transcend basic edit checks, studyOS helped Aurion identify critical issues, prevent enrollment violations, and maintain comprehensive oversight with fewer resources.
Their success proves that an in-house approach can be as effective as traditional CRO services, allowing teams to focus on what matters most: developing breakthrough treatments that change lives worldwide.
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