impact of eu ctr in your organization
TRANSCRIPT
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Impact of EU CTR in Your Organization
Vault Community Meeting
25 March, 2021
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2Copyright © Veeva Systems 2021
Agenda
Introductions & Announcements1Customer Perspective: AstraZeneca’s Approach*2EU CTR Background3EU CTR & Vault4Q&A5
*Not included in this deck.
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Barbara CanoClinical Customer Success Manager, EU R&D
Senior Director Strategy, Vault Clinical Operations
Werner Engelbrecht
Dom EatonVP Product Management, EU Vault R&D and Quality
Principal Product Manager, EU Vault RIM
Renee Menco
Head of Regulatory Process and Compliance TeamAstraZeneca
Malin Skogsberg
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Copyright © Veeva Systems 2021 4
Get insights from the latest industry news
Share best practices and learnings with industry peers
Get the most of Veeva Vault
R&D Community Hub
veeva.com/eu/rd-hub
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5Copyright © Veeva Systems 2021
21R1 Release
Mar
16-23
All Remaining General Release PODs
Pre-Release Vaults & CSV Docs Available
Pre Release Webinars
Feb
22 Initial RIA
Mar
22
Apr
09
Apr
16
Early General Release POD (VV1-2) and all Limited Release PODs
Useful links: What’s new in 21R1 | 21R1 Release resources
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6Copyright © Veeva Systems 2021
20 May, 2021
veeva.com/eu/rd-summit
Summit Connect is where the life sciences community gathers to learn
and exchange knowledge.
This year, more than 2,000 R&D and Quality experts will come together for a day of collaboration and innovative
discussions.
Register now at
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7Copyright © Veeva Systems 2021
Clinical46%
RIM12%
Clinical & RIM41%
What Vaults do today’s customers have?
97 Customers Registered for Today
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8Copyright © Veeva Systems 2021
How Familiar Are You with Clinical Trial Regulation?
23.11%
26.89%
30.25%
14.71%
5.04%
Not at all familiar - 1
2
3
4
Completely familiar - 5
Familiarity with CTR
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9Copyright © Veeva Systems 2021
Has Your Company Assessed the Impact of the Regulation?
8.82%
39.22%
26.47%
24.02%
1.47%
No
Not yet, assessment planned
Yes, assessment completed/in review
Yes, changes planned
Yes, no changes planned
Company Assessed the Impact of the Regulation from an Organizational Perspective
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10Copyright © Veeva Systems 2021
Who Will Take Ownership of Submission of Data & Documents?
8.67%
40.31%
39.80%
11.22%
Other
Both
Regulatory
Clinical
Ownership of Submission of Data & Documents
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Werner Engelbrecht, MDSenior Director Strategy, Clinical Operations
EU CTR Background
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12Copyright © Veeva Systems 2021
Clinical Trial Regulation (CTR)
• Clinical Trials carried out in EU member states currently follow Directive 2001/20,
however a new EMA Clinical Trial Regulation (CTR) is coming into effect from 31 Jan 2022.
• Key benefits of the Clinical Trial Regulation:
• Harmonised process for clinical trials conducted in multiple Member States
• Increased transparency on clinical trials data with information made publicly available
• Clinical Trial Information System (CTIS) will be the single-entry point for submitting clinical
information in the EU
• Manual interaction (data entry, file upload) – no API capabilities foreseen for next 3-5 years
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13Copyright © Veeva Systems 2021
Unchanged scope: Interventional clinical trials with medicinal products for human use
Both have EEA relevance and applicable in EEA countries and Norway, Iceland, and Liechtenstein
Key Changes from Directive to Regulation
As-is (Directive 2001/20)EudraCT
To-be (CTR)The EU Portal and Database (EU PD)
• Multiple submissions for one trial (1 submission per each Member State Concerned (MSC) / no harmonized dossier)
• Double submission within a MSC: To National Competent Authority (NCA) and to Ethics Committees (EC)
• Single e-submission via EU PD to all Member States Concerned (MSC) including NCA and EC/harmonized dossier for one trial
• Individual assessment by each MSC with no IT collaboration tool available
• Joint assessment for Part I of the dossier facilitated by collaboration tools via the EU Portal and Database IT system
• No single MSC decision (NCA & ECs) • Single MSC decision for NCA and Ethics Committees
• Limited EudraCT data availability to the public: Structured data from the application (CTA) and summary of results
• View extensive CT related information via the public version of the EU PD
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14Copyright © Veeva Systems 2021
CTR Timelines
EU CTIS audit
started
Nov 2020
All new Clinical Trials
must follow CTR
~31 Jan 2023
Transition
period 2
Transition
period 1
Notice of confirmation
published by EC
~July 2021
Directive on Clinical Trials
2001/20/EC no longer applicable
~31 Jan 2025
Regulation (EU) No 536/2014
becomes applicable (CTR)
~31 Jan 2022*
6 months 1 year 2 years
Implementation Date
<Implementation Date>
+3 years
<Implementation Date>
-6 months<Implementation Date>
+1 year * as per March 2021 EMA Board Minutes
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Dom EatonVP Product Management, Vault R&D and Quality
EU CTR and Vault
Renee MencoPrincipal Product Manager, EU Vault RIM
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16Copyright © Veeva Systems 2021
Where Does CTR Sit Within Vault Development Cloud?
• Traditional view
• Clinical is for planning, managing and conducting clinical trials
• RIM is for submission of data to attain approval and interaction with health authorities
• CTR process does not mandate a traditional submission (no xml-backbone type published output is
required), but rather the ongoing upload of clinical documents and data throughout the life of the clinical
trial
• It is a Clinical Trial process, but CTA* has typically been a regulatory process
• Vast majority of documents and data naturally reside in Clinical
• Still some activity for Regulatory steps (e.g. recording CTA* has been made, HA interaction, Product data)
*CTA=Recording the date the dossier was submitted to CTIS
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17Copyright © Veeva Systems 2021
Start Up Phase
Start Trial• Site Initiation• IMP release
• Track Study Registry per MS• Record subject visits / milestones
Study Execution
End of Study
Submit Dossier details
Notification of Decision (Approval)
Submit Start of clinical trial notifications• Start of trial in MS (per MS)
• First Subject First Visit in MS (FPFV) (per MS)• End of recruitment in MS (LPFV) (per MS)
End of Trial• Within 1 year from end of trial, prepare summary of results
• Archive TMF for 25 years after end of trial• Archive medical files of subjects in accordance with national law
Study Initiation• Record Study, Country, Site info• Generate Dossier components• Propose Reporting Member
State (RMS)
Assessment (needs tracking)• RMS validates application (within 10 days)• Part 1: RMS provides initial assessment to
Sponsor and MSs• Part 2: Each MS performs local assessment
Ongoing data collection of trial docs and data including:• Record MS Trail status / Recruitment data
• Record serious breaches and corrective measures• Unexpected events affecting benefit-risk balance
• Urgent safety measures• Inspection reports from other HAs
• Keep IB updated and review at least yearly• Safety reports and Periodic DSUR updates (Safety)
• TMF inspection ready• Adhoc assessment reports
Ongoing notifications to MSs:IB updates, Serious Breaches (within 7 days), Unexpected events, Urgent Safety Measures,
Inspection reports, Safety reports
If substantial modification of clinical trial• Prepare amended components(includes addition of Site or MSC)
Submit End of clinical trial notifications• End of Trial in MS (per MS)
• End of Trial in all MSs (all MSs)• End of Trial globally (all MSs)
• Temporary halt / resumption (all MSs)
Entry via CTIS
Post Trial• Redacted CSR to CTIS
• Summary of results (within 1 year)Vault activity
Respond to feedback on CTA
Responses to RFIs (Request for Information)Submit updated componentsChange of status: Withdrawal, Resubmission
End
Halt / Withdraw
Process Diagram
RIMClinical
RIMClinical
RIMClinical
Clinical
Clinical
Clinical Safety
Get unique study
application number
RIM
RIM
Main app
Supporting app
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18Copyright © Veeva Systems 2021
Veeva View on CTR
• The documents and data are likely to be sourced in different systems. We recommend collating the
required information in one Vault to prepare and then upload into CTIS – Vault Clinical Operations is the
best home for this.
• We are reviewing configuration best practice to manage CTR, including:
• Add new SSU Country Intelligence templates to track documents, milestones and EDLs
• Extending CTMS Issue Management to capture Unexpected Events, Serious Breaches and Urgent Safety Measures
• As CTIS has no API, we are looking at how Vault CTMS can support the transfer of data from Vault to CTIS
• [Roadmap Item] When EMA publish definitive CTIS data requirements, create a view that displays required CTIS information with export
• [Roadmap Item] When EMA provide CTIS access, we are planning to investigate if it is feasible to build some Robotic Process Automation (RPA) to help our customers file data and track what has been submitted
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19Copyright © Veeva Systems 2021
• Vault RIM will continue to be used to record Regulatory activity:
• That the CTA has been made along with the decision (as with non-EEA market registrations)
• Log/track all back and forth with the CA
• Store Product Licence & Medicinal Product definitions
Customers wanting to only use Vault RIM for CTR will require custom configuration to ensure completeness in RIM – any view or RPA feature will not be available in RIM
Veeva View on CTR
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20Copyright © Veeva Systems 2021
Tracking in Vault RIM
• Prerequisites
• Create Product Data (Product Family, Product, Product Variant, Active Substance, Excipients, Packaging)
• Create Clinical Study (associated with Product Family)
• Create one Application for the CTA
• Assign the Reporting MS as Lead Market and Concerned MSs as Application Countries
• Create Regulatory Objective (Part I, Part II, SM Part I, SM Part II, Annual Reports, CT Results)
• The system automatically creates Country Decision Detail records
• Create Submission record associated with Application and RO
• Create Registrations for each MS using the Create Registrations wizard
• Registration dates and statuses to track Start, Stop and Halt of the study in a MS
• Use Commitments to track conditions (acceptable with conditions)
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21Copyright © Veeva Systems 2021
Organizational Impact and ConsiderationsConclusions
• Veeva’s perspective is that the EU CTR should be sponsored by Clinical
• Uncertainty
• Timelines are shifting
• Pending final confirmation on specifications e.g. list of expected documents, naming conversion
• Identification of “best fit” studies to pilot process during transition period
• Consideration who will manage the CTIS portal – sponsor/CRO/central/decentral?
• Requires revision/update on internal processes/Workflows/SOPs/WIs/Country Intelligence
• Resource impact - No API capability for data entry and file upload – manual activity
• EMA: Clinical Trial Regulation
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Thank youSync all upcoming community meetings in your calendar:
go.veeva.com/clinical-calendar | go.veeva.com/RIM-calendar
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Thank you