Collect PMS data, run PMCF studies, manage PASS and PAES under EU MDR. One platform for post-market clinical follow-up, patient registries, and real-world evidence. No enterprise contract required.
Post-market clinical data collection covers every structured data activity that happens after a medical device or drug reaches the market. Under EU MDR (Regulation 2017/745), manufacturers of Class IIa, IIb, and III devices must implement Post-Market Clinical Follow-Up (PMCF) plans — actively collecting clinical evidence on safety and performance in real-world conditions, not just reusing pre-market data.
This includes PMCF studies (prospective or retrospective), Post-Market Surveillance (PMS) data aggregation, Post-Authorization Safety Studies (PASS), Post-Authorization Efficacy Studies (PAES), and long-term patient registries. These studies share a common need: structured, auditable data collection without the cost and complexity of a full interventional trial EDC. Capture.Study is built for exactly this — flexible enough for observational and registry designs, compliant enough for regulatory submission.
Most post-market data collection happens in spreadsheets or enterprise EDCs priced for Phase III. Neither is fit for purpose.
The Old Way
With Capture
Ready to replace spreadsheets with a proper PMCF platform?
How It Works
No implementation vendor. No six-month timeline. No enterprise contract.
Choose PMCF, PASS, PAES, PMS registry, or real-world evidence design. Use our templates or build from your PMCF plan. Configure visit schedules, questionnaires, and follow-up windows.
Participants complete questionnaires on any device via secure web link. No app download. Automated reminders for follow-up visits. Real-time dashboard shows enrollment and completion.
Export structured data for your PMCF evaluation report or PMS report. Full audit trail supports notified body review. Data in EU (Frankfurt) or US data centres.
Platform
Built for EU MDR compliance without the enterprise price tag. Every feature below is included in your subscription.
Configure Post-Market Clinical Follow-Up studies aligned with EU MDR requirements. Define study objectives, endpoints, inclusion criteria, and follow-up schedule in the visual study builder.
Structured forms for post-market surveillance data: complaint capture, clinical event reporting, device performance tracking, and patient outcomes at defined intervals.
Rolling enrollment with open-ended follow-up windows. Add participants at any time. Track device exposure, clinical events, and outcomes over months or years.
Schedule email and SMS reminders for follow-up visits, annual questionnaires, and overdue responses. Escalation rules alert coordinators when participants miss responses.
Track enrollment progress, completion rates, and adverse event counts in real time. Filter by site, device, implant date, or follow-up period. No manual reporting.
Export data in CSV, Excel, or SAS XPT at any time. Structured outputs align with PMCF Evaluation Report and PMS Report requirements under EU MDR Annex XIV.
Show or hide questions based on device type, implant status, or previous answers. Participants only see what is relevant. Reduces form burden and improves completion rates.
Clinical monitors review data remotely, raise queries, and track resolution. Built-in SDV workflows and monitoring visit reports without travelling to site.
Every data entry, edit, signature, and query is logged with a timestamp and user identity. Full audit history available for export to support notified body submissions and MDR Article 87 vigilance.
Run PMS data collection across multiple sites and multiple device variants in one study. Assign coordinators per site, manage permissions, and view cross-site dashboards.
Present informed consent digitally for PMCF and registry studies. Electronic signature, version control, and re-consent workflows for protocol amendments.
Host your post-market data in EU (Frankfurt) for GDPR compliance or US (N. Virginia) for HIPAA-aligned studies. Choose at study creation.
All features included. No modules to buy separately.
Post-market data submitted to notified bodies under EU MDR must be traceable, complete, and defensible. Capture.Study's audit trail and data controls are built for exactly that standard.
Every PMS and PMCF data point is captured with a full audit history: who entered it, when, from what device, and whether it was subsequently edited and why. This is the level of traceability notified bodies expect when reviewing PMCF evaluation reports.
Why Capture
PMCF studies and patient registries are typically 50–500 patients over 2–5 years. Enterprise EDCs charge Phase III prices for this volume. Capture.Study is priced for post-market reality.
EU MDR compliance deadlines are real and notified bodies are enforcing them. Capture.Study can be configured and deployed in days, not the months a traditional EDC implementation takes.
PMCF studies, PMS data collection, PASS, PAES, and registries all run in the same environment. One audit trail, one data export, one vendor to manage.
Post-market registries run for years. Capture.Study supports rolling enrollment, configurable follow-up windows, and participant re-contact without the study expiring or requiring a rebuild.
We can provide validation documentation and support for Enterprise customers preparing PMCF evaluation reports or PMS reports that reference Capture.Study as the data collection platform.
EU MDR timelines are not moving. Deploy your PMCF data collection in days, not months.
No credit card. No sales call. No commitment.