Clinical
Trial
Imaging
Management
Platform:
GaelO
The all-in-one solution for secure medical imaging orchestration and standardized central imaging review.
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Make Medical Imaging a decisional endpoint to build innovative clinical trials
« Medical imaging is wrongly seen as a complicated modality to integrate in clinical trials and thus has not yet reached its real place: a diagnostic and prognostic tool on which we can build personalized medicine. »
In clinical trials, too often imaging is not centralized — imaging data rely on local interpretation which is subject to multiple biases (non-standardized response, lack of expertise, wrong classification…).
At Pixilib we want to unlock the capabilities of medical imaging, building tools to seamlessly integrate medical imaging in clinical trials and develop new image quantifications to build new imaging biomarkers. Our goal is to provide clinically relevant image biomarkers to tailor new treatment strategies and push personalized therapy to the next level.
In current clinical trials we yet use a very limited part of medical imaging capabilities, limited to « standard » criteria known from decades. Using known validated criteria is good (and we support it) — but creating new biomarkers and building innovative uses of medical imaging is even better.
We aim to build an ecosystem to unlock the power of medical imaging and help researchers to build:
-
New prognostic group identification for per-patient treatment adaptation -
Integration of new biomarkers based on medical imaging alone or combined with biology and pathology -
New imaging technologies in clinical trials: new devices, new tracers -
Accelerate innovative trials using medical imaging as a decisional endpoint to deliver the most accurate treatment to carefully selected patients
Why GaelO is the Standard for Central Imaging and Clinical Trial Imaging
In modern drug development, medical imaging is a critical endpoint — it constitutes most of the time the objective response criteria for treatment evaluation. Collected imaging data needs to be standardized, auditable and validated.
4.2/5
User satisfaction
20
Clinical studies
10,000
DICOM studies
160
Investigator sites
400
Active users
Seamless DICOM Data Collection & De-identification
GaelO simplifies the collection of all medical imaging modalities (CT, MRI, PET…) from global investigator sites. This includes radiology and nuclear medicine but also radiotherapy, digital pathology, optical imaging or video endoscopy.
Recruiting centers only need a browser to send their images. There is no software to install on their computer or infrastructure — a user is usually able to use GaelO in minutes.
At image upload, our automated engine scrubs Protected Health Information (PHI) as specified by NEMA to ensure full GDPR and HIPAA compliance of your central imaging repository.
Central Imaging Review & Disease-Specific Criteria
GaelO provides expert readers with standardized review environments. Each expert can review medical imaging through our dedicated DICOM viewer with advanced visualization and quantification features.
According to each Clinical Trial specification, the platform integrates the appropriate Evaluation Criteria, with dedicated, customizable eCRF. GaelO supports single or multiple reviews, open or blinded reviews with decision adjudication in case of reading discordancy.
Our platform already supports the most used criteria in global clinical trial imaging research, in their latest version — see the table below.
Auditable data capture
The GaelO platform keeps in memory each data update. For each action, we track timing, data modification and the original user — delivering a full audit trail ready to be audited.
The audit trail saves all your trial history from the first inclusion to the last review, delivering a full change tracker ready to be audited at any time.
This non-alterable timeline provides strong data consistency proofs and regulatory compliance with the highest international standards for clinical research Electronic Data Capture.
Evaluation Criteria
Supported clinical trial criteria, in their latest version
Each criterion links to its reference publication. GaelO integrates these criteria as customizable eCRFs inside the reading interface — ensuring standardized data collection across centers and reviewers.
| Clinical Trial Topics | Evaluation Criteria |
|---|---|
| General Oncology |
RECIST 1.1 iRECIST PERCIST |
| Lymphoma |
Lugano Deauville RECIL DeltaSUVmax TMTV |
| Neuro Oncology | RANO |
| Myeloma | Deauville |
| Prostate Cancer |
Promise v2 RECIP PPP PCWG3 |
Core Features for Clinical Trial Imaging and Central Imaging
The GaelO platform is built with a complete set of features dedicated to a smooth management of medical imaging data in clinical trials.
A clean data structure for your clinical trial
We store medical imaging data in a clean, efficient structure built around three clear entities:
- Patients
- Visits
- Reviews
A role based access control dedicated to research collaborators
A dedicated role for each actor of your trial — Investigators, Controllers, Monitors, Reviewers and Supervisors — each with features tailored to ensure smooth, qualified data collection.
Zero footprint web platform for medical imaging data collection
Sending imaging is as easy as a drag & drop — without compromising security. No installation, automated de-identification, data consistency checks and high-speed encrypted upload. No training needed.
Real-time Quality Control (QC) for Clinical Trial Imaging
At image reception, controllers run immediate quality checks to verify protocol adherence. Non-compliant data triggers a one-click corrective request to the site — reducing costly queries later in the trial.
Real time Clinical Trial Monitoring
Track study progress at any time: data centralization, QC progression, review decisions. Built-in communication tools let you send reminders to keep every site on track toward your milestones.
Medical Imaging Visualization and Image Processing in Central Imaging
A full-feature viewer running entirely in the browser, with CRFs integrated inside the viewer itself. All modalities, all visualization tools (MPR, MIP, colormaps), quantification, registration and advanced workflows like Metabolic Tumor Volume.
Blind Independent Central Review (BICR)
From a single qualitative read to multiple blinded reads on a composite endpoint. Customized, self-explanatory eCRFs check consistency at each step, with a built-in adjudication step in case of discordancy.
Audit trail for regulatory compliance
Each modification is written to a non-alterable audit trail as required by the ICH E6(R3) Guideline — action, user and exact time. A fully auditable data timeline for your auditors.
Data availability, everywhere, any time
The data belongs to you. Standardized exports, already curated at collection time, are generated in seconds and fully ready for statistical analysis — accessible to identified users according to their permissions.
Reuse of collected data in ancillaries studies
Medical imaging is high-value data. Open an ancillary study at the end of a trial — or in parallel — and reuse all or part of the original dataset with new customized CRFs, in fully isolated workspaces.
- Isolated workspaces
- Customized eCRFs
- Instant dataset cloning
Secure & Certified Infrastructure
Clinical trial data requires the highest level of protection. GaelO is hosted on a highly secure, medical-grade cloud infrastructure compliant with international health data regulations. Focus on your science while we handle data sovereignty.
- HDS Certified
- HIPAA Compliant
- 256-bit encryption
Interoperable & API-Driven
GaelO doesn’t work in isolation. Our platform features a robust, secure REST API designed to connect effortlessly with your existing clinical trial ecosystem. Sync your imaging workflow with your current tools without friction.
- EDC & CTMS synchronization
- Automated triggers
- Standardized formats
A dedicated role for each clinical trial actor
GaelO defines a precise role for each actor of a clinical trial, ensuring smooth and qualified data collection — and structures every study around a clean, auditable data model.
Role 01
Investigators
Upload DICOM images and associated information through customizable CRFs — full-web, no installation required.
Role 02
Controllers
Run real-time Quality Control on received data and send one-click corrective requests to recruiting centers when needed.
Role 03
Reviewers
Medical experts performing centralized reading through a full-featured DICOM viewer with customizable eCRFs — multiple blinded reads and adjudication supported.
Role 04
Supervisors
Clinical trial managers with full access to imaging, CRFs, audit trail and user management — they can unlock data, edit roles and send reminders.
Role 05
Monitors
Read-only role to track the activity and data consistency of one or several participating centers.
Data Architecture
A clean data structure for your clinical trial
Every GaelO study follows a clean, hierarchical data model — making downstream statistical analysis and auditability radically simpler.
Study
N-Patients
N-Visits
DICOM images
Investigator forms
N-Reviews
Blind reads
Adjudication
Conclusion
Supported Imaging Modalities
GaelO is a multi-modal platform capable of managing the full spectrum of medical imaging used in modern research. Every modality is handled with protocol-specific precision.
Radiology
Radiography, Ultrasound, Computed Tomography, Magnetic Resonance Imaging.
Nuclear Medicine
Planar scintigraphy, SPECT, Positron Emission Tomography (PET/CT).
Radiotherapy
RTSTRUCT, RTDOSE, RTPLAN — full support of treatment planning data.
Pathology
DICOMized Whole Slide Images for digital pathology workflows.
Optical Imaging & Video
Endoscopy, dermatoscopy, ophthalmology — in DICOM format.
A new biomarker in clinical trials: Total Metabolic Tumor Volume
GaelO specializes in the automated extraction of TMTV from PET — a volumetric assessment of the entire active tumor burden, proven in Lymphoma and Prostate cancer. Whether your study uses 18F-FDG, PSMA or specialized tracers, our human-in-the-loop AI delivers robust, reproducible, regulatory-ready data.
Is GaelO for you?
A versatile, scalable platform designed for the entire clinical research ecosystem — from early-phase research to post-market surveillance.
Pharma · Biotech
Pharmaceutical Industry
Large-scale Pharma players managing Phase III global trials — our solution scales with your ambitions.
Innovation
MedTech Startups
Fast-growing MedTech startups bringing new devices and tracers into clinical research with agility.
Research
Academic & University Hospitals
Centralize investigator-initiated trials (IITs) while ensuring patient data privacy and scientific rigor.
Service Partners
CROs & Imaging CROs
Empower your Imaging CRO service offering with automated workflows and standardized central review tools.
A unified infrastructure for medical imaging research
From clinical trial centralization to research PACS and AI segmentation — three complementary products covering the full lifecycle of medical imaging in clinical research.
Clinical Trials
GaelO
Collection and centralized reading of clinical trials. From DICOM upload to Blind Independent Central Review with disease-specific criteria — GDPR/HIPAA compliant, fully auditable.
Research PACS · RWE
GaelO Flow
Research PACS for retrospective and Real World Evidence studies. Orchestrate medical imaging data: query/retrieve, batch de-identification, AI inference pipelines and seamless export.
AI · Segmentation
AI Segmentation Algorithms
FDG, PSMA, DOTATOC. Automated PET segmentation to extract Total Metabolic Tumor Volume (TMTV) human-in-the-loop, 100% medically validated, regulatory-ready.