Study Rescue

Study Rescue & Imaging Core Lab Transfer

Missed read timelines, reader turnover and slow query resolution can put a trial's database lock at risk. When that happens, changing imaging core labs can be the fastest way to get back on schedule.

Intrinsic Imaging takes over imaging studies already in progress. We move your data, align your charter and bring in experienced readers from our 750+ physician network, so the transition is controlled and fully documented across our imaging core lab services.

Our quality system has passed three FDA inspections with zero 483 observations and holds five BSI ISO certifications, so your rescued study stays inspection-ready.

Radiologist and clinical project manager beside a monitor showing a RECIST 1.1 abdominal CT comparison at baseline and three follow-ups with a study transfer progress bar

How a Core Lab Transfer Works

Step 1

Image archive transfer

We receive your existing image archive and read data, verify completeness and de-identification, and load it into our systems.

Step 2

Charter harmonization

Our physicians review your imaging charter and read design, then align them so earlier and new reads remain consistent.

Step 3

Reader mobilization

Subspecialty readers from our 750+ physician network are trained on your protocol and criteria before reads resume.

Step 4

Site re-engagement

Sites receive updated acquisition guidelines and upload instructions, with support from our team through the transition.

No reader bottlenecks

Turnaround Time & Reader Redundancy

Deep reader bench

With 750+ credentialed physicians, reads are balanced across qualified readers, so a trial never depends on one person.

Agreed turnaround times

Standard and expedited read turnaround times are agreed with you up front and tracked throughout the study.

Discrepancy & adjudication workflows

Reader disagreements are flagged and sent to an independent adjudicator, with full traceability.

A Controlled Transition for an Active Imaging Study

A core lab transfer starts with an assessment of the study’s current state, not a blanket promise that every prior issue can be reversed. We identify the data, readers, site processes and decisions needed to resume reliable imaging operations.

Inventory, Risk Assessment and Transition Plan

We review the charter, acquisition instructions, image archive, prior read datasets, open queries and expected visit schedule. The inventory distinguishes missing source images, incomplete reads and unresolved discrepancies. Sponsor-approved priorities, responsibilities and milestones define the transition plan and its dependencies.

Protecting Continuity of Earlier and New Assessments

We reconcile identifiers, timepoints, criteria versions and reader assignments before migrating data. Where methods differ, the sponsor and study team determine whether a bridging review, reread or documented mapping is appropriate. Original results remain traceable; changing providers does not silently replace previous endpoint decisions.

Backlog Management and Site Requalification

Backlog triage prioritizes safety, upcoming milestones and endpoint completeness. Readers qualify on the agreed criteria and sites receive updated transfer and acquisition instructions. Equipment or quality issues may require test submissions or retraining before new images enter production review.

Transfer Acceptance and Closeout Readiness

Acceptance checks verify archive completeness, data reconciliation, system loading and representative end-to-end reads. The team tracks remaining gaps and documents their impact on study analysis. A controlled transfer record supports later sponsor audits and regulatory review without implying that missing source data can always be recovered.

Endpoints we read

Modalities & Response Criteria Matrix

We support established and protocol-specific criteria. Imaging, endoscopy, tissue and functional assessments use distinct methods selected for your endpoints.

Therapeutic area	Modalities	Response criteria & endpoints
Oncology	CT, MRI, PET/CT, bone scan	RECIST 1.1iRECISTmRECISTRANOLuganoPCWG3PERCISTChoi
Cardiovascular	Echocardiography, cardiac MRI, CT angiography, IVUS	LVEFStrain imagingPlaque volumeValvular regurgitation grading
Central Nervous System	MRI, amyloid & tau PET, DaT-SPECT, CT/CTA	MS lesion burdenVolumetric MRIHippocampal volumetryAmyloid/Tau PETARIA-E/ARIA-HASPECTS
Musculoskeletal	X-ray, MRI, DXA, QCT	Sharp/van der HeijdeRAMRISMOAKSWORMSKellgren-LawrenceBone mineral density
Gastroenterology	Endoscopy, MR enterography, MRI-PDFF, elastography; separate histopathology	SES-CDMayo endoscopic subscoreUCEISMaRIALiver fat/stiffnessRobarts Histopathology Index
Ophthalmology	OCT, fundus photography, fluorescein angiography	Central subfield thicknessGeographic atrophy areaDR severity grading

Featured Case Study

Oncology

Rescuing a Global Phase III Solid Tumor Trial

70+ sites
CT, MRI, PET/CT
RECIST 1.1 BICR

Challenge

Midway through a global Phase III solid tumor program, the sponsor confronted a central review process with substantial operational deficiencies. The incumbent core lab's reads were marked by substantial inter-reader disagreement, and a growing backlog of unresolved queries was compromising the reliability of the imaging dataset. Protocol adherence varied widely across more than 70 sites spanning multiple continents, compounding the inconsistency of the response assessments on which the trial's primary endpoint depended. With the NDA submission timeline already fixed, the sponsor needed a partner capable of assuming control of the program mid-study without sacrificing continuity, data integrity, or regulatory defensibility.

Read the case study

View all case studies

More Study Rescue case studies

Frequently Asked Questions

When should a sponsor consider transferring to a new imaging core lab?

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.

Can Intrinsic Imaging assume responsibility for a trial already under way?

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.

What becomes of images and assessments from the previous core lab?

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.

How are readers and sites prepared for the transition?

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.

How quickly can a study rescue be completed?

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.

Must all previous images be reread after a 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.

Is your study at risk?

Tell us where your trial stands and our team will respond within one business day.

3 FDA inspections
Zero 483 observations
5 BSI ISO certifications
9001, 13485, 22301, 27001, 27018
750+ physicians
Board-certified, fellowship-trained