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Real-World Data (RWD) Research for Efficacy and Post-Market Clinical Follow-Up (PMCF)
FromBioT Medical
Today when a company launches a medical device to market, both the FDA and the EU MDR may require the company to follow up on the patients that use the device in order to monitor postmarket safety and adverse events. Furthermore, as a device company you`d probably like to know if your device is as effective in the real world as it was during the clinical trial. BioT provides you with the set of tools to both comply and analyze your device efficacy.
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- The BioT Patient Reported Outcomes (PROM) Questionnaire module allows you to build patient questionnaires, set rules on when they are delivered to patients (either upon an event like a clinical episode, or according to a preconfigured schedule), calculate answer scoring, and visualize the scoring trends over time. The questions can cover survey efficacy, side effects, or any other topic you find relevant
- The BioT Electronic Data Collection (EDC) module allows you to seamlessly integrate the RWD collected by BioT to your EDC or electronic Case Report Form (eCRF) system
- BioT provides the Anonymization & Deidentification module, which supports a plethora of data and image formats, and allows to centralize patient data in a single location for conducting big data research