Ascendis Pharma A/s · NASDAQ:ASND
Ascendis Pharma A/s — Technical Presentation (July 2024)
48 slides from Ascendis Pharma A/s's technical presentation, Jul 29, 2024
Slide 1: Patient Cloud (eCOA) Site Training
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 Patient Cloud (eCOA) Site Training Ascendis ASND0037 Dania K. A. Davie, Patient Cloud Training Specialist 29 July 2024 1
Slide 2: Agenda
Agenda Patient Cloud Overview © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 Site User Setup Participant Onboarding Study Specifics Device Logistics, Training Resources & Support Summary 2
Slide 3: Patient Cloud Overview
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 3 Patient Cloud Overview
Slide 4: Overview
Patient Cloud App – Overview The Patient Cloud App is a mobile application that collects responses to the protocol- © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 specific questionnaires throughout the study and transfers this data directly into Rave EDC. Key Featu
Slide 5: Site User Setup
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 5 Site User Setup
Slide 6: Gaining Study Access in iMedidata
Gaining Study Access in iMedidata ❑ You must have a user account in iMedidata (https://www.imedidata.com/) © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ▪ New users: select ‘Create New Account’ ▪ Existing users: you should receive an email invitation for the proto
Slide 7: Participant Onboarding
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 7 Participant Onboarding
Slide 8: eCOA Workflow
eCOA Workflow Step #1 Step #2 Step #3 Step #4 Tap Begin Patient Site Staff adds Participant in Select Subject ID and Trigger eCOA forms in Onboarding and hand Visit Number on the © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 Rave EDC Rave EDC the device to the dev
Slide 9: eCOA Triggers Workflow
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 9 eCOA Triggers Workflow
Slide 10: Site Locates Patient in Rave EDC
Site Locates Patient in Rave EDC 1. Site user must log into iMedidata and access Rave EDC for the study to add the patient 2. Site user clicks Add Subject in the upper right-hand corner of the screen, enters the Subject ID, and clicks Save © Dassault Systèmes | Confidential Information | 3/5/21 | re
Slide 11: Site Triggers eCOA Forms
Site Triggers eCOA Forms • Baseline folder → Demographics form: Is the subject 8 years or older at the time of Enrollment → Is the subject less than 18 years old at the time of Enrollment? © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 → YES → Enrollment Date → Sav
Slide 12: Site Triggers eCOA Forms
Site Triggers eCOA Forms • Baseline folder → PPQ Form Used form*: Please specify who is responding to the Patient Preference form → Save © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 Response will determine which PPQ Form will become available *The PPQ form will b
Slide 13: Participant Onboarding
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 13 Participant Onboarding
Slide 14: Site User Login
Patient Cloud App - Site User Login Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ❑ Tap the Patient Cloud App icon: ❑ Once the Patient Cloud App is open, enter your iMedidata user credentials Your iMedidata User Credentials ❑ Tap ‘Log In’ ▪ T
Slide 15: Participant Selection
Step# 3 Patient Cloud App - Participant Selection Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ❑ Select the appropriate Study from the list of available studies ▪ You will only see studies to which your account has been invited ❑ Select the
Slide 16: Visit Selection
Patient Cloud App - Visit Selection Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Select the appropriate Visit from the list of available visits ▪ You will only see visits once all EDC trigger steps have been entered in Rave EDC 16
Slide 17: ePRO
Patient Cloud App – ePRO Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 All the eCOA forms for a particular visit will be available once a visit has been selected: ❑ Patient forms (ePRO) will be listed and are grayed out because site staff can
Slide 18: Country and Language
Patient Cloud App - Country and Language Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 The following steps are completed only once, when you onboard the participant during the first ‘eCOA’ visit: ❑ Tap ‘Begin Patient Onboarding’ ❑ Tap your Co
Slide 19: Initial Participant Registration
Patient Cloud App - Initial Participant Registration Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Tap OK and hand the device to the participant ❑ The Patient Cloud App will now switch display from Clinician View to Patient View • Clinician
Slide 20: Welcome to Patient Cloud
Patient Cloud App – Welcome to Patient Cloud Participant Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Tablet is now in Patient View ❑ Welcome screen summarizes the onboarding steps ❑ Participant taps Next 20
Slide 21: Setting Participant PIN
Patient Cloud App - Setting Participant PIN Participant Activities ❑ During the first visit, the participant must set a 4-digit PIN © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 21
Slide 22: Training Mode
Patient Cloud App - Training Mode Participant Activities ❑ The participant completes a training diary (Training Mode) © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ▪ Questions are not study-specific ▪ Training is completed only during the participant’s first eCOA
Slide 23: Participant Onboarding Recap
Patient Cloud App - Participant Onboarding Recap • The onboarding process is required once per participant © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 • Each participant must: ❑ Select a 4-digit PIN ❑ Read and accept the Privacy Policy ❑ Complete the Training Mo
Slide 24: Study Specifics
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 24 Study Specifics
Slide 25: Rave eCOA CRFs (In-Clinic/Site Mode)
Rave eCOA CRFs (In-Clinic/Site Mode) The questionnaires in Rave EDC are shown in the below table Instrument Name Form Type Use Type App Mode © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 QoLISSY: Quality of Life in Short ePRO In-Clinic Site Mode on Site Device Sta
Slide 26: Protocol Specific Activities
Patient Cloud App - Protocol Specific Activities Tablet – Patient Forms Each participant is required to complete the following questionnaires at the visits listed below. © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Quality of Life in Short Stature Youth – Child
Slide 27: Questionnaire Completion
Patient Cloud App - Questionnaire Completion It is the site’s responsibility to ensure that the participant: © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ❑ Completes all questionnaires at the beginning of an eCOA visit ❑ Completes the questionnaires in the intend
Slide 28: Initial Visit
Patient Cloud App – Initial Visit Participant Activities ❑ After the onboarding process, the participant will complete each of the study- © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 specific questionnaires under the Patient View ▪ One question per screen present
Slide 29: Questionnaire Completion
Patient Cloud App – Quesionnaire Completion Tablet – Patient Activities ❑ Sample screens © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 29
Slide 30: Clinician View
Patient Cloud App - Clinician View Tablet – Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 Once the participant returns the device to site staff, check that ALL the visit-specific questionnaires are completed: ❑ A green check mark appears when
Slide 31: Tablet Visit Recap
Patient Cloud App – Tablet Visit Recap For all visits after the Initial Clinic Appointment, site staff will: © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Enter their 4-digit PIN ❑ Select the subject ID & confirm the correct visit ❑ Select the ‘Begin Patient For
Slide 32: Tablet Best Practices
Patient Cloud App – Tablet Best Practices Site Staff Activities © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Charge the device before each visit ❑ Ensure that the device is kept switched on and connected to the internet (Wi-Fi or Sim Card) ▪ This will allow for
Slide 33: Participant Compliance
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 33 Participant Compliance
Slide 34: Site/CRO Monitors Patient Compliance
Site/CRO Monitors Patient Compliance Reviewing forms in Rave EDC: 1. Site user must log into iMedidata and access Rave EDC, select site and participant © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 2. Select an ePRO form to confirm form was completed and see parti
Slide 35: Device Logistics, Training Resources & Support
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 35 Support Device Logistics Training Resources
Slide 36: Device Troubleshooting
Device Troubleshooting Restarting the Patient Cloud App: 1. Tap the home button twice to bring up a list of all currently open apps © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 2. Swipe up to close the Patient Cloud App 3. Reopen the app and continue with data co
Slide 37: Provisioned Device Package
Provisioned Device Package Sites will receive the following in Provisioned Device Packages: © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Site Device(s): 1 iPad 6th Gen per site* ❑ Device-appropriate case(s), country-specific adapter(s), and charging cord(s) ❑ D
Slide 38: Provisioned Device Package
Provisioned Device Package Upon receipt of your device shipment: © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ❑ Confirm shipment content matches shipping slip ❑ Charge the device ❑ Connect the device to your site’s Wi-Fi (or SIM card back up) ❑ Store the device a
Slide 39: Device Decontamination
Provisioned Device Packages Device Decontamination ❑ Decontamination steps should be followed between each user’s section © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ❑ Wear disposable gloves (made of latex or nitrile) ❑ Disconnect from cables and chargers before
Slide 40: Training Resources
Training Resources Site Available on imedidata.com eLearning & Show me ❏ Medidata Rave eCOA Site Mode © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 Videos Site Available electronically: Quick Reference ❏ Medidata Patient Cloud Site Mode - Visit Workflow Cards Site
Slide 41: Quick Reference Card (QRC)
Quick Reference Card (QRC) Medidata Patient Cloud Site Mode - Visit Workflow The QRC ‘Medidata Patient Cloud Site Mode - Visit Workflow’ covers the following Patient Cloud app © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 topics: ❑ Accessing Patient Forms ❑ Initia
Slide 42: Support - Sites
Patient Cloud Support - Sites Patient Cloud-Specific Helpdesk © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ❑ Site staff should email patientcloudsupport@mdsol.com for any queries relating to: ▪ The study-specific questionnaire schedule ▪ The provisioned device ▪
Slide 43: Support – Language & Availability
Patient Cloud Support – Language & Availability ❑ Patient Cloud Support is available in the following languages according to the below schedule: ▪ English -- 24x7x365 © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 ▪ Spanish, French, German -- 12x5 (9am-9pm Central
Slide 44: Country Specific Phone Numbers
Patient Cloud Support Country Specific Phone Numbers © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 Country Phone Number United States 877-338-2778 (877-DEV-ASST) 44
Slide 45: Summary
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 45 Summary
Slide 46: Thank you!
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 46 Thank you!
Slide 47: You now understand how to
Patient Cloud You now understand how to: ❑ Add a participant in EDC © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2021 ❑ Identify and complete steps in EDC to trigger necessary eCOA forms to appear ❑ Onboard a participant on a site device ❑ Train the participant on app
Slide 48: © Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023
© Dassault Systèmes | Confidential Information | 3/5/21 | ref.: 3DS_Document_2023 48