REDCap Cloud enables Medical Device and Diagnostics organizations to comply with the expanded need for safety, quality and real-world evidence as required by EU Medical Device Regulations (MDR) and Payer Reimbursement policies globally. REDCap Cloud is designed to handle the flexibility of medical device studies include instrument, apparatus, machine, contrivance, and/or implant – whether that be a feasibility, pilot or pivotal study requirement.
The world of medical device clinical research has changed dramatically in recent years. Not only are the EMEA and FDA beginning to require additional clinical evidence for approval, Payers now require real-world evidence demonstrating improvement to justify reimbursement. Capturing real-world evidence requires a unified data management approach that supports capturing data from all stakeholders including patients, clinicians, care providers, EHR systems, wearable devices, payer systems, claims data and imaging systems. Also, the range of Medical devices is vast and requires a flexible solution. Examples range from simple devices such as medical thermometers and disposable gloves to advanced devices such as orthopedic prostheses or wearable glucometers. REDCap Cloud’s flexible and Unified Data Management approach enables the right solution for each type of medical device study.
REDCap Cloud MyHealth is a direct to patient technology solution empowering patients and caregivers to directly engage on Medical Device and Diagnostics studies from the web, mobile apps or wearable devices. For example, prior to a surgery a patient could fill out validated instruments confirming their current status and fill out the same validated instruments post-surgery over periods of time confirming the quality of life improvement.
REDCap Cloud’s EHR Integration Hub makes it easy to set up and seamlessly exchange data between EHR systems and REDCap Cloud. The benefit for medical device studies is significant. For example, post-surgical notes can be entered once in the EHR and captured as source data in REDCap Cloud. Additionally, surgery dates can be automatically loaded from the EHR system into REDCap Cloud and trigger an event schedule to capture patient and clinical data.
The REDCap Cloud Validation and Compliance Virtual Data Repository provides on-demand access to IQ documentation as well as a set of templates necessary to efficiently and cost-effectively validate the implementation of REDCap Cloud. The overall solution provides auditors with the necessary tools to conduct a virtual audit, which saves an enormous amount of money and time for all stakeholders.
REDCap Cloud has developed patent-pending Software Version Management (SVM) technology that enables global scalability of the REDCap Cloud SaaS platform while simultaneously running an unlimited number of versions of REDCap Cloud EDC. The current version of the application can continue to be used without being forced to upgrade mid-study. However, you can Upgrade on Demand at any time with a single click of a button with full support and documentation for Installation Qualification (IQ) and Operational Qualification (OQ).
Our comprehensive SaaS-based Data Management platform integrates eConsent, EDC, eCOA, patient registries, surveys, and outcome tracking capabilities in a single solution. REDCap Cloud technology scales reliably and cost-effectively for research projects of all types and sizes including proof of concept, early phase studies, late phase studies, marketing support studies, surveys and questionnaires, patient registries, and outcomes research.