2016 Paperless TMF Survey: CRO Report Michael Burton Director, Vault Clinical. Copyright 2017 Veeva Systems Inc., all rights reserved veeva.

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1 2016 Paperless TMF Survey: CRO Report Michael Burton Director, Vault Clinical

2 Third Annual Veeva Paperless TMF Survey: CRO Report Understand the impact of etmf adoption among CROs on TMF processes Examine the drivers and expectations of etmf solutions Go deeper and augment industry research 2

3 Respondent Demographics Sponsor [PE RC EN TA GE] Consultant [PE RC EN TA GE] [PE RC EN TA GE] CRO Rest of World 23 % 77 % U.S. Type of organization N = 217 Geographic location N = 217 3

4 Key Findings CROs are leading the drive to active TMF management A third of CROs use an etmf application Clinical operations reducing its use of paper System integration is missing and required CROs with etmfs are improving core competencies etmfs help CROs improve inspection readiness 4

5 Types of etmfs and Use of Paper

6 Passive to Active TMF Management PASSIVE ACTIVE Paper documents; scanning Study teams do not access the TMF regularly TMF is not integrated with other clinical systems No/few manual KPIs or metrics Electronic documents managed in system Sites, CROs, and sponsor have etmf access TMF is integrated with other eclinical systems Real-time KPIs and metrics used for active TMF management 6

7 etmf System Used, CROs maturing toward Active TMF management Passive Active 26% 33% 37% 30% 16% 21% 21% 9% Local file File share Content management etmf application What type of etmf solution do you currently use? Select only one. (Q.9) Percent of CRO respondents using an etmf, 2016 N = 43, 2014 N = 43. 7

8 Clinical Operations Cutting Use of Paper TMF documents managed on paper by department 46% 45% 47% 27% 20% 37% 33% 22% Data management Regulatory Drug safety Clinical operations In each area, how many of your company s TMF documents are managed on paper at any point in their lifecycle (Q.3) Percent of CRO respondents, 2016 N=49, 2014 N=51 8

9 Digital Collaboration and Process Unification

10 CROs are Managing More Processes with an etmf Processes conducted electronically Electronic Archival of Documents Electronic Collaboration with External Partners Electronic Creation of Source Documents 59% 51% 46% 39% 40% 41% Electronic Signature of Documents CROs 19% 28% Sponsors To what extent is your company currently doing the following (electronically) with TMF documents? (Q.8) Percent of CRO respondents N=49; sponsor respondents N=137 10

11 Increasing Use of Auditable Systems for Collaboration Methods to exchange TMF documents with sponsors 80% 65% 49% 35% 18% 61% 33% 57% 45% 47% 43% 33% 31% 24% Paper Fax File share Portal ECM etmf application What methods does your team use to exchange TMF documents with external parties? Select all that apply per row. (Q.2) Percent of CRO respondents 2016 N=49, 2014 N=51 11

12 System and Process Integration is Needed Capabilities required to go paperless Digital or esignatures 53% Electronic Forms Integration with CTMS Integration with EDC Archival and Export Capabilities Tracking and Reporting Secure Access by External Parties System Compliance with 21 CFR 43% 41% 37% 33% 29% 27% 27% None Fully Paperless 16% Which capability(ies) listed is your organization currently missing and would be required by your organization in order to move to paperless TMFs? Select all that apply. (Q.5) Percent of CRO respondents, N=49 12

13 Benefits of an etmf and Use of Metrics

14 CROs Improving Their Core Competencies Benefits of an etmf Easier to Search and Find Documents 74% 69% Improved Audit and Inspection Readiness Improved Central/Remote Auditing Automated Tracking/Reporting of Documents 34% 37% 56% 50% 56% 56% Better Visibility Into Performance Metrics Easier External Collaboration Cost Savings 35% 37% 35% 32% 44% 48% CRO Sponsor What benefits were achieved with your organization s implementation of the etmf solution specified in question 9? Select all that apply. (Q.10) Percent of CRO respondents N=49; sponsor respondents N=137 14

15 etmfs Help Reduce Audit Findings Improvements in inspection finding categories Duplicate documents 40% 61% Misfiled documents 44% 53% Incomplete documents Expired documents 32% 38% 51% 51% Missing documents 47% 44% CRO Sponsor What benefits were achieved with your organization s implementation of the etmf solution specified in question 9? Select all that apply. (Q.10) Percent of CRO respondents N=49; sponsor respondents N=137 15

16 CRO Use of Metrics Grows As CROs conduct more electronic processes, they are using more data 33% 40% 46% 24% 12% 12% 17% 16% Not collecting data Rarely using data Using data in some cases Extensively using data To what extent is your organization leveraging TMF operational data (e.g., time from initial review to approval) to improve trial processes? Select one of the following (Q.14) Percent of CRO respondents, 2016 N=49, 2015 N=50 16

17 Top Drivers of etmf Adoption Inspection-readiness, visibility, cost savings Improved audit/inspection readiness Better visibility into performance metrics Cost savings Speed study start-up 35% 40% 41% 65% 67% 57% 55% 53% Remote/central oversight of TMF Easier collaboration 25% 29% 35% 48% CRO Sponsor Which of the following business benefits are the most important in motivating your organization s adoption of an etmf? Please select the top three benefits. (Q.8) Percent of CRO respondents N=49; sponsor respondents N=137 17

18 Summary CROs are leading the drive to active TMF management Unification of clinical systems is needed to go paperless CROs with etmfs are excelling at core competencies etmfs help improve inspection-readiness Study start-up remains an opportunity for CROs 18

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