eClinical Solution for MedTech Companies
Clinical Trial Management
Software for MedTech
Efficiently run clinical investigations for medical devices, diagnostics, and digital health solutions, all in one platform. From data capture to patient-reported outcomes, Datacapt adapts to your regulatory and operational needs.
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Join a Powerful Community Driving Change thanks to Datacapt
Smarter Clinical Operations for Innovative MedTech Teams
Adapt to regulatory complexity
Accelerate time to approval
Optimize hybrid and remote trials
Datacapt allowed us to automate a key and time-consuming part of our study, making the launch of a decentralized clinical trial possible.
With the right experts around you, clinical research becomes accessible.
Compliance, Flexibility, and Speed.
Finally Together
Whether you're running pre-market clinical investigations or post-market clinical follow-up (PMCF), Datacapt provides the digital infrastructure you need to streamline operations, ensure compliance, and prove device safety and performance.
Faster Study Setup
From eCRF build to first site onboarded, compared to legacy tools.
Compliant
With ISO 14155, MDR 21 CFR Part 11, audit-ready by design.
The tools Medtech teams need
All in one place
eCRF
Capture clean, compliant, and high-quality clinical data with an intuitive and customizable electronic Case Report Form
ePRO
Collect real-time patient-reported outcomes through user-friendly digital interfaces that boost engagement and compliance.
eCONSENT
Simplify the consent process with digital, compliant, and patient-friendly eConsent forms that streamline onboarding.
Recruitment
Accelerate patient recruitment with built-in tools that help you identify, screen, and enroll the right participants faster.
Scheduling
Easily manage site visits and patient appointments with automated scheduling tailored to your study timelines.
Patient Payments
Ensure timely, transparent compensation with automated patient payments that build trust and reduce administrative burden.
Frequently Asked Questions
Yes. Datacapt is fully validated and supports compliance with MDR, FDA 21 CFR Part 11, and Good Clinical Practice (GCP) guidelines, helping MedTech teams stay audit-ready across global markets.
Yes. Datacapt supports clinical investigations for Class I, II, and III medical devices, including both CE-marked and investigational products. Whether you’re running early feasibility studies, pivotal trials, or PMCF studies, our platform is flexible enough to adapt to your regulatory and operational needs.
No. Datacapt is a 100% no-code solution, designed to be intuitive for clinical, regulatory, and operational teams, no technical background required.
Absolutely. Datacapt supports multi-country, multi-language studies with centralized dashboards, role-based access, and localized user experiences, ideal for global MedTech deployments.
Yes. Datacapt offers API access for integrations with third-party systems, or connected devices, enabling real-time data exchange and streamlined operations.
Datacapt is fully compliant with GDPR, 21 CFR Part 11, and HDS standards. All data is encrypted, pseudonymized, and stored securely, with full access control and audit trails.
Other question
Our customers
say it best
From complex to seamless.
Emagina simplified data collection, accelerated study launch, and gained full control of their clinical operations.
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