BIOBOSTON CONSULTING’s Post

Transitioning from Electronic Health Records (EHR) to Electronic Data Capture (EDC) systems in clinical research can be complex but incredibly rewarding. Our latest resource dives into the strategies and solutions offered by #Cloudbyz' EDC for this transition. Join us in exploring the transformative potential of transitioning from #EHR to #EDC with Cloudbyz, and unlock the benefits of modernizing your clinical research data management: https://hubs.li/Q022XnSY0 #CTMS #eTMF #EDC #RTSM #SafetyPV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials

Today (12/22/2023), the FDA issued a final guidance document titled 'Digital Health Technologies for Remote Data Acquisition in Clinical Investigations' (available at https://lnkd.in/eC96XsZz) that finalizes the draft guidance of the same title issued on December 23, 2021 (the draft guidance is archived at Regulations.gov docket FDA-2021-D-1128). One of the major updates, from my perspective, compared to the 2021 draft guidance with the same title, pertains to the regulatory requirements of design controls, as discussed and clarified in Section III: "Therefore, where sponsors conduct the types of verification and validation activities recommended in this guidance to ensure that a DHT used only in clinical investigations for remote data collection is fit-for-purpose, FDA does not intend to otherwise assess sponsors’ compliance with design control requirements, when applicable. This policy does not apply when a DHT that is a device is intended for use outside of a clinical investigation." This clarification is of significant importance because it marks the first time in FDA guidances that the circumstances under which the FDA will not intend to assess a sponsor's compliance with design control requirements have been made explicit. Nonetheless, it's essential to note that the types of verification and validation activities recommended in this final guidance will still undergo review in an IND submission (or a separate IDE submission where applicable) to ensure the DHT is fit-for-purpose and patient safety.

Transitioning from Electronic Health Records (#EHR) to Electronic Data Capture (#EDC) systems in clinical research can be complex but incredibly rewarding. Our latest resource dives into the strategies and solutions offered by #Cloudbyz' EDC for this transition. Explore the transformative potential of transitioning from #EHR to #EDC, and unlock the benefits of modernizing your clinical research data management: https://hubs.li/Q02tRr0Q0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #Salesforce

Transitioning from Electronic Health Records (#EHR) to Electronic Data Capture (#EDC) systems in clinical research can be complex but incredibly rewarding. Our latest resource dives into the strategies and solutions offered by #Cloudbyz' EDC for this transition. Explore the transformative potential of transitioning from #EHR to #EDC, and unlock the benefits of modernizing your clinical research data management: https://hubs.li/Q02tRrRm0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #Salesforce Salesforce

Transitioning from Electronic Health Records (#EHR) to Electronic Data Capture (#EDC) systems in clinical research can be complex but incredibly rewarding! Our latest resource dives into the strategies and solutions offered by #Cloudbyz' EDC for a seamless transition. https://hubs.li/Q025dylc0 #CTMS #eTMF #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #EHR

Transitioning from Electronic Health Records (#EHR) to Electronic Data Capture (#EDC) systems in clinical research can be complex but incredibly rewarding. Our latest resource dives into the strategies and solutions offered by #Cloudbyz' EDC for this transition. Explore the transformative potential of transitioning from #EHR to #EDC, and unlock the benefits of modernizing your clinical research data management: https://hubs.li/Q02tRrRh0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #Salesforce

The majority of the implementation acts for the EU HTA Regulation have been delayed, giving pharmaceutical manufacturers even less time to prepare for Joint Clinical Assessments (JCA) which will still begin in January 2025. In our latest article, we explore how prepared Member States are for the EU HTA Regulation. If you have any concerns about your own preparations, contact us to find out how Lumanity can help you with training and readiness planning. #LumanityPerspectives #EUHTA Regulation #HEOR #HTA

Transitioning from Electronic Health Records (#EHR) to Electronic Data Capture (#EDC) systems in clinical research can be complex but incredibly rewarding. Our latest resource dives into the strategies and solutions offered by #Cloudbyz' EDC for this transition. Join us in exploring the transformative potential of transitioning from #EHR to #EDC, and unlock the benefits of modernizing your clinical research data management: https://hubs.li/Q02kbNbd0 Sign up for our webinar, "Reimagining Clinical Site Operations: Future of Unified eClinical Platforms" on Thursday, February 22 2024, at 11 AM EST: https://hubs.li/Q02kbJc00 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials