Post-Market Clinical Follow-Up (PMCF) is a crucial phase in the lifecycle of medical devices, ensuring their safety and effectiveness in real-world clinical settings. A PMCF solution like XcelTrials is designed to facilitate and streamline this process. Here are the key features and capabilities of a PMCF solution:
Collect real-world clinical data from various sources, such as electronic health records, patient registries, and medical device reports.
Create customizable data collection forms tailored to the specific requirements of the PMCF study, including data fields for patient demographics, device usage, and adverse events.
Enable data entry in real time, allowing healthcare professionals to input data as it becomes available, reducing delays and ensuring data accuracy.
Engage with patients to gather their insights and experiences with the medical device, enhancing data quality and patient satisfaction.
Include features for healthcare professionals to report and track adverse events associated with the medical device.
Ensure compliance with regulatory standards relevant to medical devices, such as ISO 14155:2020, MDR, and FDA regulations.
Implement automated data validation checks to maintain data accuracy and consistency, reducing the risk of errors.
Employ robust data security measures to protect sensitive patient information and ensure data privacy.
Generate customized reports and analytics to assess the safety and effectiveness of the medical device in real-world clinical use.
Assign roles and permissions to control access to the PMCF system and data.
Store and manage documents related to the PMCF study, including patient records, consent forms, and case reports.
Maintain comprehensive audit trails to document all changes and actions taken within the PMCF system, ensuring data integrity and transparency.
Integrate data from various sources and systems to facilitate data analysis and reporting.
Enable patients to provide informed consent electronically, simplifying the consent process.
Customize the PMCF system to match the unique requirements of the medical device and study.
A PMCF solution streamlines the collection, analysis, and reporting of real-world clinical data, supporting medical device manufacturers in fulfilling their post-market surveillance obligations and ensuring the safety and effectiveness of their products in the hands of healthcare professionals and patient
XcelTrials is a single, compliant platform for collection and management of all clinical evidence, safety, and performance data.