EDC, ePRO, and eConsent in one validated environment, with AI-assisted data extraction and an in-house data management team, so lean device teams produce EU MDR and FDA evidence without enterprise overhead.
Castor is a clinical data platform for medical device, diagnostics, and IVD companies. Device teams use it to run pilot, 510(k), CE mark, pivotal, and post-market studies, including PMCF under EU MDR, with AI-assisted chart review through Castor Catalyst and in-house data management, both available as scoped services alongside the platform. Many device teams run all three as one full-service engagement behind a single evidence plan.
Trusted by research teams running eCOA and ePRO worldwide
Castor combines electronic data capture, ePRO, and eConsent natively, so device data, patient-reported outcomes, and consent never fragment across vendors. Low-complexity studies launch in 3 to 4 weeks.
Remote and on-site consent with guardian workflows and re-consent handling, so enrollment does not stall at the signature step for distributed device populations.
Device follow-up runs on long horizons. Castor automates recurring patient surveys at the 1, 3, and 5-year check-ins device studies require, with reminders and multi-language delivery, so your team is not chasing patients manually for half a decade.
MedDRA coding for device safety data, dashboards for study health, and structured CSV and PDF exports your regulatory team can work from.
With Catalyst Site Upload, sites submit surgical notes, EMR screenshots, and paper worksheets as they are. AI-assisted extraction with human review turns them into structured study data. Zero EDC training for data entry, zero re-typing for site staff.
ePRO scheduling covers the full follow-up arc, from 30-day safety to 5-year endpoint surveys, with reminders and completion tracking your coordinators can see at a glance.
Registry, survey, and chart review designs with 21 CFR Part 11 audit trails and structured exports. 298 PMCF and post-market studies have run on Castor to date.
Manual chart review is one of the largest cost drivers in retrospective device studies. Castor Catalyst extracts structured and unstructured data from EHRs and uploaded source documents, maps it to your study database, and confidence-scores every field for human review before anything enters the record.
Catalyst under expert eyes
In a live webinar with SAGES, a practicing surgeon put Catalyst Site Upload through its paces on surgical registry documentation and gave his unrehearsed reaction on camera. For Catalyst applied to post-market follow-up economics, see the ROI of AI in PMCF session with Bassil Akra.
A newly CE-marked device starts the post-market clock immediately. PMCF is mandated, but the trigger is easy to miss, so the study is often postponed until a deadline forces it. EU MDR Article 61 makes ongoing clinical evidence mandatory for CE-marked devices unless a documented justification applies. Castor supports registry, survey, and chart review PMCF designs with structured data exports and full audit trails.
298 PMCF and post-market studies to date · 1.27M+ ePRO datapoints · 54,000+ participants across 2,140 sites
Explore PMCF on Castor ›
Watch: the new PMCF mandate, with Dr. Bassil Akra ›
Castor’s data management team handles study build, query management, coding, and ongoing data review through audit-ready delivery, so lean teams get there without building a data management department. Run your study yourself, hand it to us entirely, or anywhere in between. Together with Catalyst, this is the full-service bundle most device teams choose.
Optina Diagnostics partnered with Castor’s services team to build its initial study, then scaled to build 12 more independently on the way to FDA clearance for its AI diagnostic test.
PMCF enrollment increase at MMI
MMI met EU MDR PMCF requirements for its microsurgery robot while lifting study enrollment by 520%, with audit-ready documentation throughout.
ePRO datapoints from post-market follow-up
298 PMCF and post-market studies to date have collected 1.27M+ patient survey datapoints from 54,000+ participants across 2,140 sites.
Peer-reviewed studies from a team of 4
“You don’t survive in digital health unless you deliver outcomes and savings.” Fernando Correia, SVP Clinical Affairs, Sword Health, whose 4-person clinical team has produced 30+ peer-reviewed studies on Castor.
Recognized as a Major Contender in Everest Group’s Life Sciences eCOA Products PEAK Matrix® Assessment 2025.
Rated strongly for customer loyalty in ISR’s 2025 eCOA/ePRO Benchmarking.
Castor is a clinical data platform used by medical device, diagnostics, and IVD companies to run clinical studies across the full device lifecycle. The platform combines electronic data capture, ePRO, and eConsent in one validated environment, and offers AI-assisted data extraction through Castor Catalyst for chart review and site document upload as a scoped service, with every extraction reviewed by a human before it enters the study record. Device teams run studies on Castor across cardiovascular, orthopedics and MSK, surgical and interventional, neurology and neuromodulation, and digital health and SaMD.
Medical device teams have run 890+ studies on Castor to date, including 298 PMCF and post-market studies, enrolling 314,000+ patients across 5,100+ sites. 370+ medical device teams have used the platform to date, 144 of them active today. The platform is validated against 21 CFR Part 11, GDPR, and ISO 27001, and supports GCP-aligned device studies under ISO 14155. Teams can run studies themselves with the no-code builder, use Castor’s in-house data management services, or combine both.
Castor is a clinical data platform built for medical device, diagnostics, and IVD teams. It combines EDC, ePRO, and eConsent in one validated environment, offers AI-assisted data extraction through Castor Catalyst and in-house data management, both as scoped services. Medical device teams have run 890+ studies on Castor to date, covering first-in-human, pivotal, and post-market phases across 5,100+ sites.
Yes. Castor supports post-market clinical follow-up under EU MDR Article 61 and Annex XIV Part B, with registry, survey, and chart review study designs, structured data exports, and AI-assisted EHR extraction. 298 PMCF and post-market studies have run on Castor to date, collecting 1.27M+ ePRO datapoints from 54,000+ participants.
Castor Catalyst uses AI-assisted extraction to pull data from source documents and EHRs, cutting per-chart data collection cost from $48.75 to $9.75 and review time from 39 minutes to 6 minutes. Every extraction is confidence-scored and reviewed by a human before it enters the study record, with a post-QC error rate below 0.7% versus a 6.6% manual entry baseline.
Yes. With Catalyst Site Upload, sites upload the source documents they already have, including surgical notes, EMR screenshots, and paper worksheets. Castor extracts the data with human review, so surgeons never need EDC training and site staff never re-type source data.
Castor ePRO automates recurring patient-reported follow-up at the intervals device studies require, including 1, 3, and 5-year check-ins. Survey invitations, reminders, and multi-language delivery run automatically across mobile, tablet, and web, so study teams do not chase patients manually across a half-decade follow-up horizon.
The platform is validated against 21 CFR Part 11, GDPR, and ISO 27001, with audit trails, e-signature support, and role-based access built in. ISO 14155 governs the conduct of the clinical investigation itself rather than the software, and Castor provides the validated data capture, audit trails, and GCP-aligned workflows those investigations require.