Impact of EU CTR in Your Organization

Vault Community Meeting

25 March, 2021

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Agenda

Introductions & Announcements1Customer Perspective: AstraZeneca’s Approach*2EU CTR Background3EU CTR & Vault4Q&A5

*Not included in this deck.

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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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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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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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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Clinical46%

RIM12%

Clinical & RIM41%

What Vaults do today’s customers have?

97 Customers Registered for Today

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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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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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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

Werner Engelbrecht, MDSenior Director Strategy, Clinical Operations

EU CTR Background

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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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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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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

Dom EatonVP Product Management, Vault R&D and Quality

EU CTR and Vault

Renee MencoPrincipal Product Manager, EU Vault RIM

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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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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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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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• 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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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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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

Thank youSync all upcoming community meetings in your calendar:

go.veeva.com/clinical-calendar | go.veeva.com/RIM-calendar

Thank you