Feith Systems’ Post

EUDAMED GUIDELINE: Guidelines on Data Exchange with EUDAMED Production v 2.12 September The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their needs to comply with the Medical Devices Regulation. Although EUDAMED offers multiple ways of inputting/downloading data, there are several parameters to take into consideration before making a decision. The different data input methods are: 1. The User Interface: this option implies manual input of data through the application. 2. The XML upload/download: this option is a semi-automated one, where the data can be uploaded by means of XML files. The XML data must be validated against the provided EUDAMED DTX service and entity model XSDs. The generation of the files can be automated, but the action of uploading/downloading the files remains manual. 3. The Data Exchange (DTX) Machine-to-Machine (M2M) system: this option allows for automatic data exchange between an external backend system and EUDAMED backend services (in bulk as well). The End User enters information in the external system, and the data is automatically transmitted to EUDAMED, in XML format following the same conditions as previously mentioned without any human intervention. However, the connection of two systems in a fully automatic way may be too costly considering many architectural, technological and operational aspects (e.g. local application readiness, interoperability, infrastructure, security, support, etc.) if the frequency and/or volume of transmission remains low. This document covers only the assessment of data related to the EUDAMED modules that are available and can be used on voluntary basis: Actors registrations, UDI/Devices, and NBs & Certificates modules. #eu #eudamed #guideline

New levels of data accuracy and completeness can be achieved using OneStudyTeam to capture data which is so often incomplete or lost during the pre-randomization phase of patient recruitment.

The SCRS InFocus newsletter is live! This issue covers: ⚡ Highlights from the SCRS Global Site Solutions Summit 💻 How to automate EDC data entry by Medidata 📢 The importance of site voices and streamlining collaboration 📝 Comments on FDA's DCT Draft Guidance Read it now ⇢ https://bit.ly/330f8UR

FDA guidance promotes the use of electronic source data capture in clinical trials to improve reliability of data. See 4 ways StudyTeam’s eSource solution streamlines workflows with accuracy and data completeness: https://hubs.la/Q02cq8Ds0

Choosing the right Electronic Data Capture (EDC) vendor is a critical decision that can make or break your clinical trials. But with so many options out there, how do you find the perfect fit for your needs? Our latest blog post dives deep into the essential factors you need to consider. From understanding your requirements to evaluating vendor capabilities, we've got you covered with a comprehensive checklist. https://lnkd.in/g66eJSQK #EDC #ClinicalTrials #DataCapture #Lifesciences #Cloudbyz

Risk Evaluation and Mitigation Strategy (REMS) integrations are breaking down barriers in healthcare. Prescribers and pharmacists can now seamlessly complete REMS requirements within their workflows, eliminating the need for separate portals. This means improved communication, reduced burden, and increased access to REMS drugs. Learn more by joining the REMS public call tomorrow at 1 p.m. ET. https://bit.ly/3Z2VCSh #CodeXHL7FHIR #REMS #pharmacy

Regulatory information management platforms for data come in both centralized and decentralized formats. Veeva Systems compares the benefits of each model and provides solutions for how to balance them in your #ClinicalTrial. https://bit.ly/4b5qYix

What should one look for when choosing the right EDC for your clinical trial? Hear from Sophie Le Page, Principle Clinical Data Manager, at Fortrea and how they evaluated and adopted Veeva EDC at our Summit next week

We are excited to announce the release of #CloudLIMS version 3.92! This version empowers you to: ✔ Maintain Trace Logs for Patient Records ✔ Perform Automated Dependency Calculations While Importing a Results File ✔ Transfer Samples Between Storage Containers with Ease & do more Book a demo today! https://zurl.co/riXt #CloudLIMSVersion392 #LIMS #LIMSupgrade

In this recorded Xtalks webinar, our REMS experts discuss how the approach to assessment report metrics, audits, technology, transactional forms and FDA operation insight demands have changed and what the future holds: http://ow.ly/6x7I1054CLn #SyneosHealth