Frequently Asked Questions

Intrinsic Imaging is an ISO certified imaging core lab and imaging CRO. We support clinical trials across the full imaging lifecycle, from protocol and charter development through site qualification, image quality control, blinded independent central review and final imaging data delivery.

We support Phase I–IV pharmaceutical and biotechnology trials, Class I–III medical device trials, and artificial intelligence and computer-aided detection studies. Each imaging workflow is tailored to the study’s intended use, endpoints and regulatory obligations.

Our therapeutic expertise encompasses Cardiovascular, Central Nervous System, Gastroenterology, Musculoskeletal, Oncology and Ophthalmology. Subspecialty physicians assess imaging according to the acquisition methods, response criteria and biomarkers specified for each study.

Intrinsic Imaging holds five BSI ISO certifications spanning quality management, medical device quality management, business continuity, information security and the protection of personally identifiable information in the cloud. We have also completed three FDA inspections, each concluding with zero Form FDA 483 observations.

Yes. Our network spans 4000+ imaging centers in 64 countries, supported by 750+ board-certified and fellowship-trained physicians. For ongoing studies, our study rescue services encompass image archive transfer, charter harmonization, reader mobilization and site re-engagement.

An imaging core lab is a central facility that standardizes image acquisition across trial sites, receives and quality-checks every examination, and provides blinded, independent interpretation by qualified readers according to the criteria set out in the imaging charter. Its purpose is to generate consistent, unbiased imaging endpoints on which regulators can rely.

An imaging core lab is warranted whenever imaging supports a primary or key secondary endpoint, the study spans multiple sites or scanner types, the design calls for blinded independent central review, or a medical device or AI/CAD product is to be evaluated against an expert reference standard.

Ideally before the protocol and imaging schedule are finalized. Early review clarifies acquisition requirements, endpoint feasibility and central-reading dependencies. We can also assume responsibility for an active study through a controlled transfer.

Typical turnaround is 24–48 hours for image quality control, 24–72 hours for eligibility and safety reads, and 5–10 business days per batch for efficacy reads. Standard and expedited timelines are agreed in the imaging charter and monitored throughout the study.

Yes. A responsibility matrix agreed at startup defines site communication, query ownership, safety escalation and data transfers among the core lab, the sponsor and the clinical CRO.

Yes. We support Class I–III medical device trials as well as stand-alone and multi-reader multi-case AI/CAD observer performance studies. Our services include controlled case handling, reader training, blinded assessments and traceable imaging evidence aligned with the medical device’s intended use and study protocol.

Readers are drawn from our network of 750+ board-certified and fellowship-trained physicians according to therapeutic expertise and the study’s assessment requirements. Protocol-specific training aligns readers on the imaging charter, applicable criteria and documented review procedures before assessments begin.

Our five BSI ISO certifications underpin controlled processes for quality, security and continuity. Study documentation, image handling and assessment records are maintained for full traceability and audit readiness, supporting sponsor submissions to authorities such as the FDA, EMA and PMDA.

Five BSI ISO certifications (9001, 13485, 22301, 27001 and 27018), a quality management system established in 2011, and three FDA Bioresearch Monitoring inspections (2012, 2018 and 2021), each concluding with zero Form FDA 483 observations.

Our services encompass imaging protocol and charter development, site qualification and training, acquisition standardization, secure image collection, quality control, independent central reads, adjudication and imaging data management. Scope is defined around the study’s imaging endpoints and delivery milestones.

The imaging charter defines the assessment criteria, reader qualifications, blinding requirements and read paradigm. Subspecialty readers evaluate images independently, using single, double or triple-read designs and adjudication workflows selected to satisfy the protocol’s requirements.

We establish protocol-specific acquisition guidelines, evaluate site equipment and train imaging personnel before activation. Central quality control then verifies incoming images for completeness and acquisition compliance, while documented queries resolve any issue that could affect endpoint assessment.

Yes. Remote site qualification, site training and secure cloud image upload enable decentralized and hybrid trial models. Portable imaging workflows are evaluated against protocol requirements, equipment suitability and acquisition quality standards before use.

Deliverables are agreed in the imaging charter and data transfer specifications. They may include reader assessments, quantitative imaging measurements, adjudicated results, reconciled imaging datasets and supporting documentation, with traceability from image receipt through final delivery.

Yes. Our scope may encompass a complete imaging workstream or discrete activities such as acquisition guidance, site qualification, quantitative analysis, independent reads or study transfer. Responsibilities and interfaces are documented at kickoff.

We track them against the expected visit schedule, distinguish technical failures from missing examinations, and apply the protocol’s query and analysis rules. A scan is never designated evaluable merely to complete a dataset.

Each process step has a defined starting and completion point. Charter development, for example, runs from study kickoff to charter sign-off; image receipt confirmation, from site upload to confirmation; and efficacy reading, from batch lock to completed reader assessments.

The imaging charter is typically finalized within about 20 business days of kickoff, and the reading system is typically ready within about 15 business days. These are distinct startup milestones whose dependencies and sequence are agreed for each study.

Receipt confirmation is typically issued on the same business day as site upload. Image quality control generally yields a QC result or query within 24–48 hours of upload. The QC milestone is the issuance of that result or query, not necessarily the resolution of every site query.

Eligibility and safety reads typically take 24–72 hours from a QC-passed case to a completed reader assessment. Efficacy and endpoint reads typically take 5–10 business days per locked read batch. Adjudication and final delivery follow the imaging charter’s data-cutoff and closeout schedule.

No. Published figures reflect typical expectations. Standard and expedited timelines are agreed with the sponsor, documented in the imaging charter and monitored throughout the study, taking into account the protocol, case volume, image readiness and delivery milestones.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Neither. GAMP 5 is ISPE’s good-practice guidance for a risk-based approach to compliant GxP computerized systems, offering a lifecycle framework. It does not confer FDA approval or supersede applicable regulations. Intrinsic Imaging’s five ISO certifications are distinct from this validation framework.

Supplier documentation can contribute to the evidence package, yet suitability still depends on intended use, configuration, interfaces and risk. Our approach weighs reusable supplier evidence alongside the verification required for the actual imaging workflow.

Not necessarily. A documented change-impact assessment determines which requirements and controls may be affected, and verification and regression testing address those functions and risks. A documented decision precedes any use of the changed system.

No. FDA’s Computer Software Assurance for Production and Quality Management System Software guidance addresses software used in medical device production or quality management systems. Clinical investigation systems must be evaluated against their own applicable requirements and FDA’s guidance on electronic systems in clinical investigations.

Computerized-system validation demonstrates that the software supporting the imaging workflow is fit for its intended use and preserves reliable records. AI/CAD clinical validation evaluates an investigational product’s clinical performance. The two are complementary activities with distinct evidentiary objectives.

A platform’s technical features represent only part of the assessment. Applicability, intended use, configuration, user permissions, operating procedures, training and retained evidence are equally relevant. A product label neither establishes that a particular study workflow is validated nor demonstrates that every applicable requirement is satisfied.

Cloud hosting does not remove validation or record-control obligations. Qualification considers the service provider, configuration, interfaces, security, changes, recovery, retention and access to records, and the evidence must address the actual intended use and the responsibilities assigned to each organization.

Yes. Read sequencing, access permissions, measurement rules, visit mappings and export formats can affect the reliability of study records even when the underlying software is unchanged. The validation scope therefore addresses these settings and the risks introduced by the configured workflow.

Pertinent evidence includes the system’s intended use and configuration, requirements, risk assessment, supplier review, verification traceability, test results, assessed deviations and release decision. Change control, training, access administration, audit-trail review, recovery and retention arrangements demonstrate how the validated state is maintained.

Yes. Intrinsic Imaging conducts stand-alone and multi-reader multi-case observer performance studies, drawing on experience from 55 large MRMC AI/CAD studies.

Our support spans protocol and imaging study design collaboration, case selection, dataset development, reference-standard establishment, reader recruitment and qualification, image and data quality control, reader training, blinded execution, adjudication and final data delivery.

Reader panels are matched to the clinical indication, imaging modality, intended use and regulatory objectives, drawing on more than 750 board-certified, fellowship-trained physicians.

Intrinsic Imaging has supported multiple FDA-cleared AI/CAD/Viewer technologies, completed an MRMC AI/CAD/Viewer trial inspection with zero Form FDA 483 observations, and maintains ISO 13485 certification for medical device clinical trial services. Clearance decisions rest solely with the FDA.

We support 510(k), De Novo and PMA submissions for Class I, II and III medical devices.

Our experience encompasses implanted medical devices, stents, catheters, embolization and stroke medical devices, drug delivery medical devices, biopsy equipment, biologics, and AI/CAD/diagnostic software.

Yes. Our ISO 13485 certification covers the provision of imaging core lab services for medical device trials.

Our readers interpret echocardiography (2D/3D), cardiac MRI and MRA, stress MRI, cardiac and vascular CTA, angiography, ECG, MUGA, PET, SPECT, nuclear cardiology, ultrasound and thoracic CT/MRI/HRCT.

Yes. The Cardiovascular Imaging division supports clinical trials evaluating both cardiac safety and cardiovascular efficacy.

Reads are performed by more than 150 board-certified, fellowship-trained cardiologists and cardiothoracic radiologists.

Our experience includes Alzheimer's disease and its variants, multiple sclerosis, Parkinson's disease, Huntington's disease, epilepsy, stroke and cerebrovascular disease, brain tumors, traumatic brain injury, spinal disorders, schizophrenia and other conditions.

CNS imaging is interpreted by more than 100 board-certified, fellowship-trained neuroradiologists.

Yes. We support CT and MR perfusion, diffusion and diffusion tensor imaging, and spectroscopy.

No. They may serve as primary, secondary, safety or exploratory measures, depending on the protocol and supporting validation. We define that role and the analysis method with the sponsor before reads begin.

Yes. Endoscopy is centrally reviewed alongside CT, MRI and nuclear imaging.

Our experience includes IBD, ulcerative colitis, GERD, IBS, short bowel syndrome, ulcers and related abdominal and pelvic conditions.

Gastroenterology data are reviewed by more than 60 board-certified, fellowship-trained gastroenterologists.

Yes, including endpoints for joint-space width, cartilage, structural progression and inflammation.

Yes. DXA and quantitative CT are core musculoskeletal modalities.

Musculoskeletal imaging is interpreted by more than 100 board-certified, fellowship-trained musculoskeletal radiologists.

We support all major oncology criteria, including RECIST 1.1, iRECIST, mRECIST, irRC, Lugano, Cheson, Choi, RANO, RANO 2.0, Macdonald, PCWG3, PERCIST, IWCLL, BI-RADS and protocol-specific methodologies.

Yes. Our oncology radiologists conduct blinded independent central review and adjudication under standardized, protocol-specific review methodologies.

We support CT, MRI, PET/CT, SPECT, bone scintigraphy and ultrasound, including diffusion, perfusion, volumetric and quantitative PET methods, across Phase I through IV studies.

Yes. We configure separate assessments and data fields for each protocol-defined framework, such as RECIST 1.1 and iRECIST, preserving independent response rules and traceable results.

Our board-certified ophthalmologists have participated in more than 160 ophthalmology clinical trials as principal investigators or reviewers.

Yes, together with color fundus photography, fluorescein angiography and adaptive optics imaging.

Yes, including BCVA, visual fields, ERG, full-field stimulus testing and IOP.

A transfer may be warranted when missed read timelines, reader turnover, unresolved image queries or data reconciliation problems jeopardize trial milestones. The decision begins with a review of current imaging status, outstanding work and the requirements for a controlled transition.

Yes. Intrinsic Imaging routinely assumes imaging studies already in progress. The transition encompasses existing image archives and read data, charter alignment, reader training and site communications, with responsibilities and milestones documented before reads resume.

We receive the available image archive and read data, verify completeness and de-identification, and reconcile the transferred records. Our physicians review the existing charter and read design to determine how earlier assessments and new reads can remain consistent and traceable.

Subspecialty readers are trained on the protocol, response criteria and imaging charter. Sites receive updated acquisition guidance and upload instructions, together with operational support to resolve outstanding queries and establish the new image submission workflow.

The schedule depends on archive size, data completeness, charter alignment, outstanding queries and reader requirements. We evaluate these dependencies with the sponsor and establish a study-specific transition plan rather than applying a fixed timeline to every transfer.

Not necessarily. That decision depends on prior read quality, consistency of criteria, available source data and the study’s analysis requirements. We document the assessment and agree on any bridging or reread scope with the sponsor.

The library contains 25 imaging core lab case studies spanning study rescue, oncology BICR, AI/CAD reader studies, medical devices, Cardiovascular, CNS, Gastroenterology, Musculoskeletal and Ophthalmology. Each examines a sponsor objective, an imaging challenge and the central review approach adopted.

Case studies are organized by category, allowing sponsors to focus on their therapeutic area or study type. Relevance also depends on the imaging endpoint, acquisition modality, reader design and operational challenge, not the indication alone.

No. Sponsor identities remain confidential, and the library focuses on imaging objectives, review strategies and study execution rather than on identifying sponsors or individual participants.

A case study offers a valuable starting point, but the imaging workflow must be tailored to the new protocol. Acquisition requirements, assessment criteria, reader expertise, blinding and data delivery are defined around the sponsor’s specific endpoints and study population.

Certainly. Our team can review your protocol, imaging endpoints, study timeline and current operational challenges to determine an appropriate scope of support. For an ongoing trial, the discussion can also address archive transfer, outstanding reads and transition requirements.