Imaging CROs & Pharma

CalibraMics safeguards multimillion-dollar clinical trials by ensuring imaging biomarkers remain robust, reproducible, and regulatory-grade.

In oncology, respiratory, and neurology trials, CT imaging biomarkers—such as tumor volume, density, or texture-derived radiomic features—are increasingly central to evaluating drug efficacy. However, the success of these biomarkers depends on consistent and drift-free imaging data. Variability introduced by scanner differences, protocol deviations, or site-specific practices can silently erode biomarker reliability, threatening trial outcomes and regulatory approval.

CalibraMics provides Imaging CROs and Pharma with a proactive solution:

• Harmonized Imaging Across Sites – standardizes CT data across multiple trial centers and scanner types, ensuring that biomarkers are comparable and trustworthy.
• Continuous Drift Monitoring – detects and flags scanner-induced data drifts during the trial, preventing data degradation before it impacts biomarker analyses.
• Regulatory-Ready Quality Assurance – supports adherence to FDA, EMA, and ICH imaging standards by providing auditable, quantitative evidence of imaging consistency.
• Reduced Trial Risk & Cost – by safeguarding imaging endpoints, CalibraMics reduces the likelihood of costly trial delays, failed endpoints, or rejected submissions.

For iCROs and pharmaceutical sponsors, CalibraMics acts as both a quality assurance layer and a risk mitigation tool, protecting trial integrity, accelerating biomarker validation, and increasing confidence in imaging-driven decisions.