From Outsourcing to In-House Excellence: How a Clinical-Stage Biotech Transformed Clinical Operations with SiteroAI

Executive Summary

When a clinical-stage 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 SiteroAI, the sponsor 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

1.5 Hours

Daily time saved per team member

$16,500

Annual savings per team member

66%

Data review time reduction

8.8/10

User satisfaction score

The Challenge: Maximizing Impact with Minimal Resources

The sponsor is developing an investigational advance therapy, an investigational single-administration allogeneic cell therapy. Their Phase I/II clinical trial 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, the 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 SiteroAI Solution: Technology Meets Strategy

SiteroAI transformed the sponsor’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 SiteroAI automatically integrating all study data and the team fully trained and operational.

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 SiteroAI saves me about 1.5 hours each day because everything I need is right there.”

— Clinical Operations Team Member

“SiteroAI provides valuable information by adding context to the data, drawing comparisons between timepoints, and identifying issues based on the study protocol.”

— Clinical Operations Team Member

“Had I had to go into EDC, I think it would have taken me triple the amount of time.”

— Clinical Operations Team Member

Clinical Excellence: Results

Industry Recognition

Clinical Trial Success

Over 18 months, the sponsor successfully:

  • Enrolled and dosed nearly 100 subjects in their Phase I/II trial
  • Advanced a second clinical study in parallel
  • Secured multiple FDA expedited program designation

Conclusion: Redefining Clinical Operations

This 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, SiteroAI helped the sponsor 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.