Advanced Clinical’s Post

kerri weingard of Verified Clinical Trials (VCT) shares innovative strategies to combat the challenge of duplicate participants in clinical trials. This issue threatens data integrity and patient safety, making VCT's technology a crucial development in the field. Here's a snapshot of the insights and future plans highlighted: * VCT's database prevents dual enrollment, enhancing trial integrity. * Their technology ensures participant safety by avoiding adverse drug interactions. * Data privacy is prioritized, adhering to global regulations. * Future advancements include facial recognition for participant verification and patient tokenization to engage the community. #ClinicalTrials #PatientSafety #DataIntegrity #Innovation #HealthcareTechnology

Join us at the 16th Annual Next Generation Dx Summit, where Beaufort’s SVP, Global Regulatory and Quality, Karin A. Hughes, Ph.D. will be presenting on “Clinical Trials with CDx—Navigating the Complexity of the IVDR”. The IVDR has increased the complexity of clinical trials using companion diagnostics (CDx). With the delay in the implementation of Eudamed’s Clinical Investigations & Performance Studies module, sponsors must follow different national procedures and reporting for each Member State where CDx studies are conducted. This presentation explores the challenges sponsors face and provides solutions from our experience supporting combined studies across the EU. We are now scheduling appointments to discuss this topic and other emerging trends that can impact your product development. Schedule your appointment today at: https://lnkd.in/ez8TkSiD Learn more about our Companion Diagnostic solutions: https://lnkd.in/gx3NNYKK #ClinicalTrials #CDx #IVDR #NGDx

The article examines how the adoption of decentralized clinical trials (DCTs) involving digital data collection and telemedicine has increased industry confidence and learning, but also emphasizes the challenges of managing, integrating, and securing the diverse data generated by DCTs while adhering to data privacy regulations highlighted in the FDA's May 2023 draft guidance on DCTs. #decentralizedclinicaltrials #datacollection #dct #diversedata

As technology advances and clinical innovations such as digital endpoints and biomarkers become more prevalent in the life sciences industry, the regulatory considerations surrounding them grow in complexity. Learn how to navigate this evolving space, with insights from this free webinar. Experts from Biofourmis will discuss: -Traditional versus digital measures in clinical research and their key differences. -The current regulatory framework for digital endpoints, including regional disparities. -Regulatory considerations for data integrity and security, validation and reliability, and patient safety and privacy. -How to Integrate digital endpoints into trial protocols. -Emerging and regulatory trends and future regulatory direction. Sign up for our webinar today: https://ow.ly/zXRk50R4zCg #DigitalHealth #ClinicalResearch #Biomarkers

As technology advances and clinical innovations such as digital endpoints and biomarkers become more prevalent in the life sciences industry, the regulatory considerations surrounding them grow in complexity. Learn how to navigate this evolving space, with insights from this free webinar. Experts from Biofourmis will discuss: -Traditional versus digital measures in clinical research and their key differences. -The current regulatory framework for digital endpoints, including regional disparities. -Regulatory considerations for data integrity and security, validation and reliability, and patient safety and privacy. -How to Integrate digital endpoints into trial protocols. -Emerging and regulatory trends and future regulatory direction. Sign up for our webinar today: https://ow.ly/zXRk50R4zCg #DigitalHealth #ClinicalResearch #Biomarkers

ICON’s approach to clinical trial tokenisation marries patient data and real-world insights, reshaping the way we understand drug safety and efficiency. In an article published in Intelligent https://ow.ly/XMe750Qk2BU, Kathleen Mandziuk, Vice President, eClinical Development and Delivery at ICON, sheds light on this innovative leap forward in healthcare. Read the article to learn more about ICON’s dedication to data privacy and regulatory excellence: https://ow.ly/Cvel50Qk2EW #Tokenisation #realworlddata

Now confirmed, new proposals to extend the transition periods for certain IVDs (with specific scenarios), propose mandatory use of EUDAMED modules (after audited) as early as Q4 of 2025. #eudamed #medtech #regulatorycompliance

SURVEY: Sharing and accessing individual patient data from clinical trials Although transparency and data-sharing initiatives bring significant value to trial participants, researchers, and healthcare providers, awareness of these initiatives and their real-world impact is yet to be explored. To do this, Krystelis is conducting a prospective, survey-based, cross-sectional study through separate questionnaires for clinical trial researchers and investigators.   The questionnaires assess awareness and opinions about clinical trial transparency, responsibility towards the informed consent process, specifically the privacy protection of trial participants, and other related topics. Guest blog by Shalini Dwivedi and link to the survey here: https://lnkd.in/dKtzcw3s #clinicaltrials

Breaking: Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply. "This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions.  Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs." #medicaldevices #invitrodiagnostics #medtech #EUMDR #EUIVDR #EUDAMED #supplychainmanagement

🧪 Ever wondered about the exceptions to informed consent for IVD trials? You're not alone! Our latest blog dives deep into when and why informed consent might be skipped in in-vitro diagnostic trials. Understand the regulations, ethical considerations, and real-world applications. Read the full blog here: https://hubs.li/Q02Gt4BS0 📺 Missed our webinar on IVD Trials? Watch it on-demand now and gain invaluable insights: https://hubs.li/Q02Gt03S0 #Cloudbyz #IVDTrials #InformedConsent #ClinicalResearch #Webinar