With the EU MDR date of application fast approaching, medical device manufacturers strive to find ways to comply with the updated requirements on PMCF. The updated requirements for PMCF pose a great challenge on how to collect data on clinical performance and safety. SMART-TRIAL Cases is the latest product from SMART-TRIAL, which is designed to simplify the collection of PMCF data and comply with the EU MDR.
Legacy medical devices are no longer exempt from the new EU MDR. This means that legacy devices need to comply with the same requirements as any other medical device on the market. This poses a great challenge for many, especially those who have never collected any clinical data before.
From May 2021, all devices need to have a PMCF plan, which specifies how the manufacturer plans on collecting, analysing, and reporting on their device’s clinical performance and safety.
Post-market clinical investigations (or PMCF studies) is one the first methods that come into mind as a way to collect clinical data for PMCF. As such, a range of companies are planning to comply with the PMCF requirements by conducting observational clinical investigations in a post-market setting.
But convincing clinical experts to plan and conduct a clinical investigation on legacy devices is not a simple task. Thousands of legacy devices are used in healthcare on a daily basis, and planning a study on every single legacy device to comply with the requirements on PMCF is both costly and time consuming. Not to mention uninteresting for scientific research, which is what most clinical experts are interested in when collaborating with the industry.
After eight years of servicing MedTech companies with Electronic Data Capture and eClinical solutions, SMART-TRIAL’s product team felt compelled to innovate its service offering to help tackle this challenge. By combining our expertise in electronic data capture and surveys with experience from early stage PMCF projects, SMART-TRIAL Cases was created.
SMART-TRIAL Cases brings the best of SMART-TRIAL eCRF, ePRO and Survey into one product. The goal of SMART-TRIAL Cases is to make it as easy as possible for clinical experts to deliver real-world-evidence through prospective data collection.
The vision behind SMART-TRIAL Cases is to offer a minimalistic version of an EDC system closer to clinical teams. But at the same time, in order for manufacturers to pass the scrutiny of Notified Bodies, SMART-TRIAL Cases has to ensure traceability of data and compliance with GCP as well.
See the workflow of SMART-TRIAL Cases here:
By using a smartphone or a laptop, clinical staff can quickly open SMART-TRIAL Cases either during or after application of a medical device in practice, and deliver data on performance and safety parameters. This can be done once or multiple times throughout the day, or as needed/requested by the manufacturer, for as many cases (or patients) as needed.
When data has been captured, the manufacturer has a complete overview of all the case-series registered in the platform, and full traceability of where it came from, and who entered the data - which ensures GCP compliance and further enhances the validity of the data.
Furthermore, with the help of SMART-TRIAL’s Forms, manufacturers can utilize all the advantages of the eCRF features to adapt Forms according to different devices or product families. This enables manufacturers to keep track of all PMCF data on products within the same family - all in one place. No need to create projects or studies for each device.
SMART-TRIAL Cases enables compliance with ISO 14155:2020, FDA CFR21 Part 11, and EU GDPR, by taking care of all system validation and requirements specifications and documentation through the existing quality management processes at SMART-TRIAL.
SMART-TRIAL is launching the 2021 product webinar series on the 20th of January 2021 at 14:00 CET. The first webinar will be presenting SMART-TRIAL Cases, and by using the button below, you can attend the webinar and learn more about how SMART-TRIAL Cases works in practice.
To find out how SMART-TRIAL Cases can fit into your PMCF plan you can contact our experts below.
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