Oncology Imaging Services

Your Scientific Imaging Endpoint Expert

From early-phase RECIST 1.1 reads to advanced PET quantification, radioligand therapy dosimetry, and AI-enhanced endpoint analysis, MERIT delivers the imaging depth today’s oncology pipeline demands.

  • 14+ Years of Imaging Expertise
  • 1,521+ Collective Clinical Studies Completed
  • 300+ Board-Certified Readers Worldwide

Why MERIT – And Why Now

The oncology pipeline has evolved. Your imaging CRO should too.

The Shifting Oncology Landscape

The dominant therapies reaching sponsors’ pipelines today — Antibody-Drug Conjugates (ADCs), Radioligand Therapies (RLTs), Bispecific Antibodies, and CAR-T Cell Therapy — demand imaging endpoints that go far beyond tumor size measurement. Sponsors need a partner with the scientific depth to connect imaging strategy to where their drug is actually headed.

Beyond RECIST 1.1: Three Tiers of Tumor Assessment

Modern trials increasingly layer all three assessment types within a single protocol. A RECIST-only CRO can no longer compete.

Anatomical Endpoints

CT/MRI-based. RECIST 1.1, iRECIST, RANO, PCWG3. Did the tumor shrink? MERIT has deep live capability across all standard criteria.

Functional Endpoints

FDG PET, DCE-MRI, DWI/ADC. PERCIST, Lugano/LYRIC, PCWG4. Is the drug changing tumor biology before size changes? Critical for bispecifics, CAR T, IO combinations.

Molecular Endpoints

PSMA PET, ImmunoPET (89Zr), FAPI PET, radiomics & features. RECIP 1.0, emerging frameworks. Is the drug reaching the right target? Essential for RLT, advanced ADC trials, and theranostics.

MERIT’s Foundational Advantage

Since 2012, MERIT has operated as a dedicated imaging CRO. Our singular focus translates directly into client value: faster study start-up, deeper protocol expertise, and a team that speaks your science.

Founded 2012 (as EyeKor; rebranded MERIT CRO)
Global Team 200+ employees; 300+ board-certified readers worldwide
Studies Completed 1,521+ clinical studies supporting 200+ FDA/EMEA regulatory filings
Platform EXCELSIOR™, FDA 510(k)-cleared, cloud-based imaging platform
Partnerships 30+ general CRO partners; global site network across all geographies
Recognition Inc. 5000 Fastest Growing Private Companies for 8 consecutive years

EXCELSIOR Technology Platform

Purpose-built for oncology imaging trials. No other platform compares.

The FDA-Cleared Oncology Imaging Trial Platform
EXCELSIOR™ is MERIT’s proprietary, FDA 510(k)-cleared cloud platform—the central nervous system of every study we manage. Unlike general-purpose platforms adapted for imaging, EXCELSIOR was built from the ground up for the rigors of oncology clinical trial image management.

EX TechPlatform
Convenient

Cloud-based single platform with instant deployment. No software to install, no firewall configuration. Sponsors, CROs, and sites are operational in days, not months.

Transparent

All stakeholders get role-based real-time access to images, study progress, image status, query history, and read status: 24/7 from any location globally.

Configurable

Fully customizable workflow handles any response criteria, read paradigm, or adjudication model. Designed for trials with complexity without the associated cost premium.

Integrated

Built-in query messaging, audit trail, real-time notifications, and direct sponsor data warehouse transfer eliminates the need for separate integrations.

AI-Enhanced with human oversight

Active AI/ML pipeline for automated data collection, lesion measurement validation, pattern recognition, and read quality assurance eliminates human error and variability.

Audit-Ready

Complete audit trail at every step. Annotated and unannotated images, read data, query logs, and all study documents are accessible and locked at close-out.

EXCELSIOR Technology Platform

Purpose-built for oncology imaging trials. No other platform compares.

The FDA-Cleared Oncology Imaging Trial Platform
EXCELSIOR™ is MERIT’s proprietary, FDA 510(k)-cleared cloud platform—the central nervous system of every study we manage. Unlike general-purpose platforms adapted for imaging, EXCELSIOR was built from the ground up for the rigors of oncology clinical trial image management.

EX TechPlatformMobile
Convenient

Cloud-based single platform with instant deployment. No software to install, no firewall configuration. Sponsors, CROs, and sites are operational in days, not months.

Transparent

All stakeholders get role-based real-time access to images, study progress, image status, query history, and read status: 24/7 from any location globally.

Configurable

Fully customizable workflow handles any response criteria, read paradigm, or adjudication model. Designed for trials with complexity without the associated cost premium.

Integrated

Built-in query messaging, audit trail, real-time notifications, and direct sponsor data warehouse transfer eliminates the need for separate integrations.

AI-Enhanced with human oversight

Active AI/ML pipeline for automated data collection, lesion measurement validation, pattern recognition, and read quality assurance eliminates human error and variability.

Audit-Ready

Complete audit trail at every step. Annotated and unannotated images, read data, query logs, and all study documents are accessible and locked at close-out.

EXdiagram

EXCELSIOR is a simple, easy to navigate system. Queries are clearly defined. In comparison to the competitor software we use for many other trials, I would say you have the superior product overall, especially for ease of uploads.
-Site Coordinator, EXCELSIOR User

Fastest Study Start-up in the Industry

MERIT’s streamlined implementation process means EXCELSIOR can be configured, tested, and live with readers trained and sites onboarded faster than many competitors. A 30% reduction in study start-up time has been demonstrated in real-world retrospective studies.

Sponsor Kick-off to FPFV Industry-leading turnaround; charter, configuration & UAT in parallel
Site Onboarding Early site surveys, SIV materials, and 24/7 support during activation
Reader Training Indication-specific and criteria-specific modules
Study Reports Real-time cumulative reports on exam receipt, queries, and read status

Scientific & Medical Expertise

500+ oncology studies. 20+ cancer types. Every imaging modality.

A Medical Affairs Program Built for Today’s Trials

MERIT’s Medical Affairs team provides scientific support that extends far beyond standard image review. Our oncology team connects sponsor science to endpoint strategy: advising on imaging protocol design, response criteria selection, and regulatory alignment from pre-IND through submission.

Oncology Solid Tumors, Hematology & Neuro-oncology

Scientific and medical expertise at MERIT

Criteria Mastery for Efficacy & Safety outcomes

  • RECIST 1.1 & iRECIST, modified RECIST
  • RANO / RANO LGG / RANO 2.0
  • PET RANO 1.0
  • Lugano / LYRIC
  • PERCIST
  • PCWG3 & PCWG4
  • RECIP 1.0 (PSMA-PET)
  • Deauville, Hallek
  • Safety monitoring for ILD and pulmonary fibrosis

Modality and assessment

  • CT / MRI (all anatomical)
  • PET-CT / PET-MR
  • SPECT-CT
  • DCE-MRI / DWI-ADC
  • Bone Scintigraphy
  • Novel radioisotope tracers targeting PSMA, SSTR, LAT, and other biomarkers (89Zr, 18F, 64Cu, 68Ga etc.)
  • Volumetric analysis tumor growth kinetics SUV, TBR, MTV, and other tracer uptake measurements

Therapeutic Areas

  • Solid tumors (all types)
  • Neuro-oncology / Glioma / Brain metastasis
  • Prostate / Urology
  • Lymphoma / Hematology
  • Neuroendocrine tumors
  • Rare oncology indications

A Reader’s Perspective on MERIT’s Oncology Imaging Services

Team Collective Experience Profile

Oncology page graphic
Experience profile mobile
Biliary Tract Cancer
Criteria: RECIST 1.1
Total Studies: 4
Colorectal Cancer
Criteria: RECIST 1.1
Total Studies: 13
Gastric Cancer
Criteria: RECIST 1.1
Total Studies: 7
GI Stromal Tumor
Criteria: RECIST 1.1/depends
Total Studies: 6
Pancreatic Cancer
Criteria: RECIST 1.1
Total Studies: 5
Liver Cancer/Hepatocellular Carcinoma (HCC)
Criteria: RECIST 1.1/depends mRECIST
Total Studies: 15
Melanoma / Skin
Criteria: RECIST 1.1/iRECIST
Total Studies: 19
Brain Cancer / Metastasis
Criteria: RANO/RANO BM
Total Studies: 25
Head & Neck Cancer
Criteria: RECIST 1.1/depends
Total Studies: 17
Thyroid Cancer
Criteria: RECIST 1.1
Total Studies: 6
Multiple Myeloma
Criteria: IMWG2016
Total Studies: 4
Leukemias
Criteria: LUGANO
Total Studies: 5
Lymphomas
Criteria: LUGANO
Total Studies: 89
Lung Cancer
Criteria: RECIST 1.1/NELSON
Total Studies: 90
Mesothelioma
Criteria: mRECIST Mesothelioma
Total Studies: 7
Cervical Cancer
Criteria: RECIST 1.1
Total Studies: 6
Ovarian / Cervical / Endometrial Cancer
Criteria: RECIST 1.1
Total Studies: 22
Non-Hematological Malignancies, Solid Tumors
Criteria: RECIST 1.1/iRECIST
Total Studies: 73
Breast Cancer
Criteria: RECIST 1.1
Total Studies: 53
Sarcomas
Criteria: RECIST 1.1
Total Studies: 4
Prostate Cancer
Criteria: RECIST 1.1/PCWG3
Total Studies: 23
Renal Cell Carcinoma
Criteria: RECIST 1.1/NELSON
Total Studies: 11

Centralized Image Storage Solution

Designed for early phase studies:
  • Cost & time savings through prospective collection of study images
  • A secure, centralized location for curated images accelerates drug development timelines when central review is needed
  • MERIT’s image collection leads to improved image quality & reduced variability among various study sites
Program is an annual subscription-based service that consists of:
  • Image collection and quality check, site support
  • Project management services
  • Project start-up documents (abbreviated imaging charter, site survey, site manuals, project plan)
  • MERIT staff to perform image check-in and quality control review
  • Centralized storage & access to view the processed radiologic images on the EXCELSIOR platform
  • Processed images will be DICOM image files that are stored after the Check-in with PHI removed

Centralized Image Storage Case Study

A global, commercial-stage biopharmaceutical company launched a Phase II study with patients at various sites in the US and EU to assess a novel therapeutic agent using PET imaging of solid tumors using RECIST 1.1. MERIT provided image collection and quality checks, site support, and project management services, as well as quarterly and as needed image transfers, offering the flexibility required for the partially retrospective study.

Recent Case Studies Using EXCELSIOR

Cs time savings

Glioma: Time Savings Gained in Retrospective Study of Glioma

Cs cost saving

Glioblastoma: Cost Savings in Newly Diagnosed Glioblastoma Multiforme (GBM) Trial

Radioligand Therapy: A Dedicated Capability

As radioligand therapies (RLT) reshape prostate cancer and neuroendocrine tumor treatment, MERIT has built a dedicated RLT imaging review service. Our service combines nuclear medicine physicians, physicists, dosimetry expertise, and proprietary quantification workflows. MERIT’s integrated reading platform fully supports PET and nuclear medicine viewing with a configurable workflow. This enables the complex workflows required for companion diagnostic tracer and theranostic agent trials.

Diagnostic Review

Precise tumor visualization, SUV quantification, TBR measurements, biodistribution characterization using PSMA-PET, SSTR, FAPI, and novel tracers.

Theranostic Assessment

Post-treatment response using response criteria such as RECIP 1.0, PERCIST, and PCWG4. Longitudinal therapeutic efficacy monitoring across all RLT modalities.

Dosimetry Services

Organ and tumor dosimetry, voxel-based patient-specific dosimetry, MIRD phantom dosimetry. Supports alpha and beta emitters per MIRD/ICRP guidelines.

Site QC & Certification

Imaging acquisition QC, injection parameter review, site calibration support — ensuring data quality from the scanner to the database.

Reader Network: Depth and Breadth

Our 300+ readers span board-certified radiologists, neuroradiologists, nuclear medicine physicians, oncologists, and physicists at leading academic medical centers worldwide. Every reader is trained to the specific indication, modality, and response criteria of your study.

Reader Pool 300+ worldwide; board-certified across radiology, neuroradiology, nuclear medicine
Collective Trial Experience of MERIT Core Readers 1300+ clinical trials across various cancer indications in phase I, II, and III
Academic Credentials Professors, Associate/Assistant Professors, Department Chairs of major academic medical centers
Study-Specific Training Indication-specific, criteria-specific, charter-specific training for every study
Quality Monitoring Ongoing read quality assessment, variability tracking, re-training protocols
KOL Network Oncology KOLs, medical oncologists, neuro-oncology specialists, nuclear physicists, imaging scientists, and other radiopharmaceutical experts
Rare Disease Coverage Dedicated KOL engagement program for uncommon indications

Where MERIT Wins Outright

Imaging Focus

Unlike others that offer broad CRO services across many therapeutic areas, MERIT is a dedicated oncology imaging specialist. Every process, every reader, every tool is tuned for oncology.

Real-Time Sponsor Transparency

Role-based 24/7 access for all stakeholders—sponsors, CRO monitors, and sites—is a standard MERIT offering, not an add-on. Competitors typically offer limited or delayed sponsor visibility.

No Hidden Fees

MERIT's transparent, milestone-based billing model is unique in the market. Monthly invoices reflect only completed work, which reduces financial risk for sponsors of all sizes.

Fastest Implementation

MERIT's streamlined configuration and UAT process gets studies live faster. Case studies demonstrate 30% time reduction at study start-up providing a direct competitive advantage in time-sensitive trials.

Proprietary FDA-Cleared Platform

EXCELSIOR™ is FDA 510(k)-cleared: a regulatory distinction that very few of our competitors match with their core imaging platforms. This matters in regulatory submissions.

Scientific Partner, Not Just Vendor

MERIT's Medical Affairs program engages sponsors earlier in trial design, advising on endpoint strategy, protocol design, and regulatory positioning before vendor decisions are finalized.

Collaborate with MERIT

Start a conversation. Start a study. Start winning faster.

What Working with MERIT Looks Like

MERIT functions as an extension of your study team, not as a black-box vendor. From the day you engage us, you gain direct access to project managers, medical affairs scientists, imaging experts, and your dedicated operational team.

Step 01

STUDY START-UP

Charter finalization, EXCELSIOR configuration, UAT, reader training, and site materials provided on the fastest timeline in the industry

Step 02

ONGOING MANAGEMENT

Risk tracking, query management, reader monitoring, real-time sponsor reporting, and site support are proactive and transparent throughout

Step 03

SCIENTIFIC SUPPORT

Medical Affairs team available for endpoint consultations, protocol review, response criteria guidance, and regulatory intelligence

Step 04

STUDY CLOSE-OUT

Full audit package, annotated/unannotated images, locked data, and complete query history are ready for regulatory submission

Step 05

POST-STUDY

Data analysis support, publication and evidence-generation collaboration, and biomarker endpoint performance analysis

Client Testimonial Video

Our Commitment to You

MERIT’s mission is straightforward: together with sponsors, we drive innovative therapies to bring relief to patients and families worldwide. We achieve this by delivering the most reliable technologies, the best customer service, the strictest attention to detail, and the fastest response time in the industry.

Reliability
ISO 13485-compliant QMS, ISO 27001-compliant ISMS, robust SOPs, successful sponsor and regulatory agency audits. Your data is secure, compliant, and audit-ready.
Agility
Oncology-only focus means we adapt faster than generalist CROs. New modalities, emerging criteria, novel trial designs—we build the capability you need.
Transparency
EXCELSIOR provides every stakeholder with real-time visibility. No surprises. No delays in critical information. Just clear, actionable study data.

Client Testimonial

“

I want to thank the MERIT team for working so closely with us to accomplish the blinded review of the scans from our Phase 1/2a study. It was a huge accomplishment to be able to complete this, and I greatly appreciate the collaboration with MERIT that made this possible. Your team is absolutely amazing!”

-CHIEF MEDICAL OFFICER, ONCOLOGY BIOTECH COMPANY

Ready to Elevate Your Imaging Strategy?

Contact our oncology team to discuss your study from early-phase BICR to complex multi-modality endpoint programs.

Let's Make Your
Project a Reality

Connect with us to learn more about how our expertise and approach can support bringing your product to market on-time and on-budget. Your success is our priority.