Clinical Trial Imaging Technology From First Scan to Final Data

One Controlled Imaging Record

Technology Across the Complete Trial Lifecycle

Technology is most valuable when every stage shares the same study logic. Select a stage to see how the configured system, imaging specialists and quality controls work together.

1. Study Design: Translate the protocol into a controlled imaging workflow before the first participant is scanned. Technology controls: Study-specific imaging charter and acquisition requirements; Defined visits, modalities, assessments and response criteria; Configured roles, review sequence, adjudication rules and data outputs. Expert oversight: Imaging specialists examine how each endpoint will be acquired, reviewed and delivered, then align the technical configuration with the approved study design. Sponsor value: A precise operating model reduces ambiguity at sites and gives every downstream system and team a common set of rules.
2. Site Setup: Prepare sites, scanners and technologists to produce consistent images across the trial network. Technology controls: Equipment surveys and scanner capability review; Protocol-specific acquisition parameters and test submissions; Phantom qualification where required by the study. Expert oversight: The project team reviews equipment readiness, training completion and qualification evidence before routine study imaging begins. Sponsor value: Early standardization limits avoidable variation between sites, scanner manufacturers and acquisition teams.
3. Secure Image Intake: Receive imaging records through a controlled process that protects privacy and preserves traceability. Technology controls: Secure electronic image transfer and DICOM handling; De-identification controls for participant information; Assignment to the correct participant, visit and modality. Expert oversight: Exceptions in identifiers, expected content or submission context are resolved before an exam advances to clinical review. Sponsor value: A controlled intake process protects the chain of custody and keeps the image connected to the correct study timepoint.
4. QC and Reconciliation: Check every submission against the imaging charter and reconcile the imaging record with study expectations. Technology controls: Protocol-based completeness and technical quality checks; Expected-versus-received exam tracking; Documented site queries, corrections and resubmissions. Expert oversight: Imaging personnel distinguish technical defects from protocol deviations and direct clear questions to the site when correction is possible. Sponsor value: Problems are addressed before they reach the reader or accumulate near an interim analysis or database lock.
5. Central Review: Route qualified exams into a blinded, study-specific reading environment. Technology controls: Single-, double- and triple-read configurations; Role-based task assignment and blinded information display; Electronic assessment forms built around the charter. Expert oversight: Subspecialty physicians apply the defined criteria, measurement conventions and reviewer instructions for the clinical indication. Sponsor value: Structured review reduces interpretive variability while preserving reader independence and a reviewable assessment record.
6. Quantitation and Adjudication: Apply quantitative methods and resolve reader disagreement without weakening the blind. Technology controls: Longitudinal measurements and imaging biomarker assessments; Study-specific discordance rules and adjudication routing; Traceable assessment versions and resolution outcomes. Expert oversight: Qualified analysts and adjudicators review the relevant images and evidence under the rules established for the trial. Sponsor value: The final imaging assessment reflects a controlled method rather than an informal reconciliation after the fact.
7. Data Delivery: Convert completed imaging assessments into reconciled, sponsor-ready data and documentation. Technology controls: Controlled mappings, units, precision and transfer specifications; Reconciliation between source assessments and released datasets; Delivery packages prepared for analysis and regulatory review. Expert oversight: Project and data teams review completeness, resolved exceptions and release readiness before an authorized transfer. Sponsor value: Sponsors receive imaging data whose meaning can be traced from the delivered record back to the underlying assessment.
8. Retention and Retrieval: Preserve the records and context needed for sponsor oversight, audit and inspection. Technology controls: Protected retention of images, assessments and essential metadata; Applicable audit trails and change history; Backup, recovery and accurate record-retrieval controls. Expert oversight: Access, retention and retrieval follow controlled procedures throughout the required record lifecycle. Sponsor value: The study record remains available and intelligible after active reading has ended.

How Blinded Central Review Protects Your Imaging Endpoints

A controlled review pathway keeps image quality, independent interpretation and endpoint resolution connected—without compromising reader blinding.

Specialized Study Models

One Technology Framework, Configured for Different Evidence Questions