Intrinsic Imaging's Physician Reader Network

Subspecialty Expertise by Therapeutic Area

The network is organized by therapeutic area, providing a foundation for matching reader expertise to a study's clinical requirements. The figures below count each physician once, under the principal area of interpretation. Many physicians hold additional subspecialty qualifications and contribute to studies across more than one area.

Within these therapeutic areas, Intrinsic Imaging selects readers for their experience with the specific indication and assessment method. A solid-tumor study using RECIST 1.1, a glioma study using RANO and a lymphoma study using Lugano therefore require different combinations of clinical and interpretive expertise, even though all three fall within oncology.

This approach also applies to multi-reader multi-case (MRMC) studies for AI/CAD submissions, where reader selection reflects the algorithm's intended clinical application. Drawing on the same network, Intrinsic Imaging has engaged more than 200 radiologists in a single study.

Clinical Credentials and Reader Qualification

Before admission to the network, each physician undergoes a documented review of credentials and clinical experience. Intrinsic Imaging verifies identity, medical licensure and board certification directly with the issuing authorities, then evaluates fellowship training, years in practice, subspecialty case volume and previous clinical trial interpretation experience.

Board certification and fellowship training must be appropriate to the endpoint. Depending on the assessment, this may involve radiology or nuclear medicine, cardiology for echocardiography, ophthalmology for retinal imaging, or gastroenterology for endoscopic video review. Relevant fellowships include body imaging, neuroradiology, musculoskeletal radiology, cardiothoracic imaging, nuclear medicine and retina. Certification is reverified at defined intervals; a lapse suspends reading eligibility until the credential is restored.

Qualification also establishes the reader's independence and understanding of trial obligations. Intrinsic Imaging assesses potential conflicts involving sponsors, investigational products and participating sites, records financial disclosures, and confirms Good Clinical Practice and procedural training, including blinding and data-integrity requirements. A reader agreement formalizes confidentiality, independence and quality-system obligations. Externally engaged physicians are managed as suppliers under the same requirements.

Protocol-Specific Training and Study Qualification

Once a physician is qualified to the network, Intrinsic Imaging determines suitability for an individual study by considering the indication, imaging modalities and protocol-specified response criteria. Assignment then requires a separate qualification process against the study's imaging charter and reading manual; network membership alone does not authorize trial interpretation.

Training translates the protocol into a consistent approach to image assessment. Readers review the imaging schedule, lesion-selection and measurement rules, response criteria, atypical scenarios and adjudication triggers. They then complete study-specific qualification cases and must achieve the charter-defined agreement threshold before interpreting participant images.

That qualification remains tied to the instructions governing the study. If the imaging charter or reading manual is amended, readers undergo retraining, and the training record identifies the applicable document version. This maintains the connection between the approved assessment method and the physician performing it.

Ongoing Performance Review

After study qualification, oversight shifts from readiness to performance. Intrinsic Imaging assesses intra-reader agreement by re-presenting a sample of previously interpreted cases, while inter-reader agreement and adjudication rates are reviewed by reader pair and over time against the assumptions underlying the study design. Together, these measures characterize consistency within and between readers.

Interpretive consistency is considered alongside operational performance. Assessment timeliness is monitored against the commitments on the Turnaround Times page, and quality-control query and correction rates are examined for patterns requiring attention. When agreement falls below the charter-defined threshold, documented retraining is initiated and subsequent performance is reviewed before the reading restriction is lifted.

These activities operate within Intrinsic Imaging's quality management system, certified to ISO 9001 and ISO 13485 by BSI. Monitoring records are available to sponsors and support regulatory inspection; reader performance oversight was examined during each of Intrinsic Imaging's three FDA Bioresearch Monitoring Program inspections, all of which concluded with zero Form FDA 483 observations.

Reader Removal and Assessment Continuity

If retraining does not restore the required agreement, Intrinsic Imaging removes the reader from the study. Removal is also required when a conflict of interest arises, certification or licensure lapses, or assessment timeliness cannot be maintained. In each circumstance, the decision and its rationale are documented within the quality management system.

The transition addresses both completed work and future assessments. Previously completed reads are evaluated for potential impact under the nonconformance procedure, and a replacement physician is trained and qualified against the same imaging charter before assignment. Intrinsic Imaging informs the sponsor of the change and its assessed implications for the imaging endpoint.

Sponsor Review and Study Planning

Sponsors can review the proposed reader model before study initiation by requesting physician curricula vitae, Intrinsic Imaging's reader-qualification procedure and sample monitoring reports under a confidentiality agreement. Available at any stage of the proposal process, these materials allow the sponsor to consider clinical expertise, study qualification and performance oversight together.

For a protocol-specific discussion of reader selection and assessment requirements, reach Intrinsic Imaging through the Contact Us page or arrange a meeting through the Events page.