-
Kick off
-
Green light Technical Validation Study (TVS)
Month 6 - Completed
Green light Technical Validation Study (TVS)
Month 6 - Completed
Sponsor and Ethical approval granted to all centres involved in technical validation study. Operative definitions of RWS, WB and metrics for secondary digital mobility outcomes defined and validation data available for algorithm refinement
-
Novel methodology validation plan - EMA Briefing Book
Month 6 - Completed
Novel methodology validation plan - EMA Briefing Book
Month 6 - Completed
First plan for EMA regulatory qualification of Mobilise-D methodology
-
Stakeholder network established
Month 8 - Completed
Stakeholder network established
Month 8 - Completed
Initial inventory of relevant stakeholders established, Preliminary material to disseminate MOBILISED-D objectives and results among stakeholders
-
Stage 1 EMA Qualification Advice received
Month 12 - Completed
Stage 1 EMA Qualification Advice received
Month 12 - Completed
Feedback to the Briefing book and Mobilise-D methodology
-
Data Requirements Agreed for TVS
Month 13 - Completed
Data Requirements Agreed for TVS
Month 13 - Completed
Requirements gathered with all stakeholders and the data requirements specification for the technical validation study is locked down.
-
First patient TVS
Month 13 - Completed
First patient TVS
Month 13 - Completed
Algorithms and evaluation criteria ready for comparison on existing data, Technical validation enabled (limits of accuracy of gold standards defined and algorithms and device location(s) selected)
-
HTA briefing package
Month 16 - Completed
HTA briefing package
Month 16 - Completed
Share information with HTA and obtain their support for Mobilise-D activities
-
Green light for Clinical Validation Study (CVS)
Month 19 - Completed
Green light for Clinical Validation Study (CVS)
Month 19 - Completed
Approval from Study Sponsor to start and ethical approvals on their way for CVS in DE, FR, ES, IL, IT, NO, UK
-
Stage 2 QA received from EMA
Month 20 - Completed
Stage 2 QA received from EMA
Month 20 - Completed
Second qualification advice from EMA
-
Data Requirements Agreed for CVS
Month 20 - Completed
Data Requirements Agreed for CVS
Month 20 - Completed
Requirements gathered with all stakeholders and the data requirements specification for the clinical validation study is locked down.
-
Patient and Public Advisory Group
Month 21 - Completed
Patient and Public Advisory Group
Month 21 - Completed
Setup and Action Plan - Implementation of Patient Engagement and Involvement strategy and establishment of Stakeholder boards and fora
-
Data Management Platform for CVS
Month 25 - Completed
Data Management Platform for CVS
Month 25 - Completed
Data management platform in place for clinical validation study. This platform incorporates the tool required for data capture, ingestion, storage and analysis of the different data-sets required in the clinical validation study protocol. Platform designed and implemented using ALCOA+ principles.
-
First patient CVS
Month 25 - Completed
First patient CVS
Month 25 - Completed
Enrollment of the patients in the CVS started and coordinated in all the testing sites
-
First summer school - Interaction with MedTech industry
First summer school - Interaction with MedTech industry
Hackathon
-
HTA for payers and authorities
HTA for payers and authorities
Report dissemination
-
CVS preliminary data
CVS preliminary data
Preliminary results publication
-
Second summer school
Second summer school
Digital Mobility Assessment module workshop
-
First Results published
First Results published
Mobilise-D Open Access data
-
Mobilise-D regulatory Submission
-
Final conference
Month 60
Mobilise-D
Mobilise-D
Timeline
You are here:
- Home
- Timeline
This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Cookie settingsACCEPT
Privacy & Cookies Policy
Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.