Clinical Trial Imaging Technology From First Scan to Final Data
Clinical trial imaging does not succeed through software alone. It requires a controlled environment in which the protocol, imaging charter, clinical expertise and electronic record remain connected from study setup through final delivery.
Intrinsic Imaging uses validated technology to organize global image collection, protect participant privacy, identify acquisition problems, manage blinded central review and preserve the traceability of every assessment. Our specialists remain accountable at each decision point. Technology makes their work consistent, visible and reviewable.
The result is more than an image repository. It is an end-to-end operating framework built around the reliability of your imaging endpoints, the efficiency of participating sites and the evidence sponsors must defend during audit and regulatory review. See how this framework supports our imaging core lab.
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.
Stage 1 of 8
Study Design
Translate the protocol into a controlled imaging workflow before the first participant is scanned.
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.
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.
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.
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.
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.
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.
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.
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.
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.
01
Independent Assessment
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.
Site Images
Protocol-defined acquisition and secure submission.
Intake & Quality Control
Identity, completeness and acquisition checks.
Reader A
Independent, blinded assessment.
Reader B
Independent, blinded assessment.
Assessment Comparison
Apply the charter’s concordance and discordance rules.
Adjudication When Required
Resolve qualifying discordance; concordant assessments proceed directly to reconciliation.
Endpoint Data
Reconciled assessments and traceable data delivery.
Illustrative dual-reader pathway. The imaging charter defines the reader model, blinding rules, discordance criteria and when adjudication is required.
Purpose-Built Around the Study
The Technology Functions Behind Reliable Imaging Endpoints
Each function is configured to the protocol and governed within the same quality framework. This preserves clinical meaning as images move from the acquisition site to the final dataset.
Study Configuration
The protocol becomes a study-specific operating model: visits, modalities, acquisition rules, assessment forms, reader roles, adjudication logic and delivery specifications are defined before use.
Global Image Operations
Secure intake, DICOM handling, participant de-identification, visit assignment and protocol-based quality control organize imaging from geographically distributed clinical sites.
Decentralized and Hybrid Trials
Remote site qualification, virtual technologist training and secure cloud upload let community hospitals, regional imaging centers and portable-modality settings contribute images under the same central quality control and blinded review.
Central Reading Workflows
Technology supports blinded single-, double- and triple-read paradigms, independent review, adjudication and study-specific electronic assessments across imaging specialties.
Quantitative Imaging
Configured tools and controlled methods support lesion measurement, volumetric analysis, functional measures, imaging biomarkers and longitudinal comparisons appropriate to the endpoint.
Data Management
Identifiers, visits, image records, assessments and released results are reconciled across the workflow. Transfer specifications preserve content, units, precision and clinical meaning.
Quality and Validation
Intended-use validation, role-based access, audit trails, controlled change, recovery testing and record retention support reliable electronic records and inspection readiness.
Sponsor Command View
Know Where the Imaging Workstream Stands
Effective oversight requires more than a final report. Study reporting organizes the operational signals that reveal whether sites are submitting the right exams, quality issues are being resolved and central review is progressing toward delivery.
The exact measures, reporting cadence and data views are defined for each study.
Expected and Received
Track planned exams against submissions by participant, visit, site and modality.
Quality-Control Status
Distinguish accepted exams from submissions awaiting review, correction or resubmission.
Open Site Queries
Follow unresolved acquisition, identification and completeness questions to closure.
Reading Progress
Monitor assignment, completion and readiness across independent review stages.
Adjudication Status
Identify discordant assessments and follow required resolution without exposing blinded information.
Delivery Readiness
Review reconciliation and exception status before an authorized data release.
Built for Regulated Evidence
Data Integrity, Security and Continuity by Design
The controls behind the workflow matter as much as the visible features. Intrinsic Imaging connects intended-use validation with information security, cloud privacy and business continuity disciplines across the electronic record lifecycle.
Validated Intended Use
GAMP 5 principles and applicable FDA expectations guide requirements, risk-based verification, release and controlled change.
Access, Blinding and Audit Trails
Unique roles, study-specific visibility and reviewable histories protect accountability and independent assessment.
Information and Cloud Privacy
ISO 27001 and ISO 27018 controls govern information security and personally identifiable information in cloud environments.
Continuity and Recovery
ISO 22301 disciplines support continuity planning, protected records, backup, recovery and reliable retrieval.
Support device placement, performance and safety assessments through controlled imaging workflows aligned with Class I, II and III development programs.
Manage case datasets, reference standards, reader assignments, reading sessions and large observer-performance datasets within a controlled study environment.
Bring existing image archives, prior assessments and unresolved queries into a reconciled operating model without losing the history needed to interpret the record.
CT is one of the most widely used modalities in clinical trials, and a substantial literature, led by RECIST 1.1, governs how lesions are measured. Far less attention is paid to how the images are acquired, yet patient motion, scanner variability, slice thickness and contrast timing all add error to every measurement. FDA's 2018 guidance on imaging endpoint process standards makes acquisition a regulatory concern. A few basic principles, written into the protocol and imaging charter and applied consistently at every site, substantially improve data accuracy.
Orthopedic trials have long depended on patient questionnaires and on radiographic joint space width, a measurement of what cannot be seen. Quantitative MRI measures cartilage, bone and soft tissue directly, in three dimensions, and can reveal biochemical change before structural loss occurs. Validated scoring systems for rheumatoid arthritis, consensus profiles for compositional cartilage imaging and metal artifact reduction techniques for implants have made MRI a practical endpoint across arthritis and device trials. This issue reviews those methods and what sponsors must standardize to use them well.
Echocardiography is safe, portable, affordable and available worldwide, which makes it one of the most practical imaging tools for clinical trials. It measures chamber size, function, valves and mass, and changes in these measures predict major cardiovascular events, allowing smaller trials and earlier answers. Since the first edition of this issue, global longitudinal strain and three-dimensional echocardiography have become standard measures, and cardio-oncology guidelines now define cardiac injury from cancer therapy partly by strain. Standardized acquisition and core-lab reading remain essential.
Which imaging modalities does the technology workflow support?
The workflow accommodates DICOM and other study imaging across CT, MRI, PET/CT, SPECT, radiography, ultrasound, echocardiography, DXA, OCT, fundus imaging, angiography, endoscopy and protocol-specific formats. Configuration, quality checks and assessment tools are selected for each study rather than imposed through a single generic workflow.
Can the workflow accommodate decentralized and hybrid trials?
Yes. Facilities closer to participants, such as community hospitals and regional imaging centers, can be qualified remotely through equipment surveys, test submissions and virtual training. Qualified sites upload images securely via the cloud, and the same central quality control and blinded review apply wherever the participant was scanned.
How is each study configured?
Configuration begins with the protocol, imaging charter and data-transfer requirements. Intrinsic Imaging then defines visits, modalities, expected submissions, quality checks, reader roles, blinding, assessment forms, adjudication rules and outputs, establishing the basis for controlled setup and verification.
How does the workflow safeguard participant privacy?
Secure transfer, de-identification controls, role-based access and controlled handling protect imaging records throughout intake, review and retention. Study identifiers preserve the clinical relationship among participant, visit, image and assessment without exposing information a user is not authorized to view.
Does the workflow support independent blinded review?
Yes. Study-specific roles and visibility rules support independent single-, double- and triple-read designs, over-reads and adjudication. The configured sequence governs what information each reader may see and when a case advances to the next step.
Which operational information can sponsors review?
Study reporting can present expected and received examinations, quality-control status, open site queries, reading progress, adjudications and delivery readiness. The precise reporting scope and cadence are defined according to the study and its oversight needs.
How does Intrinsic Imaging validate the software used in its workflow?
Our risk-based approach links intended use, requirements, study configuration and verification evidence. It applies GAMP 5 principles and relevant FDA expectations to the functions that safeguard participant safety, blinding, endpoint integrity and regulated electronic records.
Can imaging data be transferred to sponsor systems?
Yes. Data-transfer specifications define identifiers, field mappings, units, precision, file structure, delivery method and reconciliation. Intrinsic Imaging works with each sponsor to define the appropriate interface rather than relying on a presumed one-size-fits-all integration.
What does final data delivery include?
Deliverables are defined by the protocol and transfer specification and may include reconciled central-review data, imaging assessments, quantitative results, adjudication outcomes and supporting documentation. Release checks confirm that delivered data agree with the controlled source assessments.
Design the Technology Workflow Around Your Trial
We'll align imaging operations, review controls and data delivery with your protocol and endpoints.
