welcome - veeva systems · ®2014 veeva systems – company confidential veeva.com | 10 initial...

Welcome

®2014 Veeva Systems – Company Confidential veeva.com | 2

Agenda

Why Another Survey?

Initial Findings

What’s Next?


Why Another Survey?


2013 TMF Reference Model Survey n = 226


58%

22%

Paper eTMF

81%

26%

Paper eTMF

2012 TMF Ref Model Survey #2

62%

18%

Paper eTMF

Source: 2012 TMF Survey #2, Drug Information Association, November 2012.

Audit Preparation and Response

Ensuring TMF Completeness

Maintaining Quality

BETTER

71% BETTER

68% BETTER

63%

Survey respondents indicating processes are hard or very hard


2013 State of Trial Master Files

Source: State of Trial Master Files, 2013

Challenges companies face managing essential documents

and trial master files

* Top challenge for those using paper

~Top challenge for those using electronic system

* ~

* ~ ~

*

*


Veeva’s Goal: Go Deeper

Build on prior surveys

Understand “why”

Drill down to understand nuance and drivers

Not just what barriers are, who’s creating them?

Fourteen survey questions – most matrix

Source of paper: by department, by external partner, by doc lifecycle

Barriers to paperless: organizational, technical, external

Type of eTMF

Benefits of eTMF

Use of metrics


Conducting the Survey

Fierce Market – largest database of life science contacts

n=260 respondents – largest TMF survey to date

Qualified: Answered “yes” to question: “Are you one of the primary people

responsible for a Trial Master File within your organization?”

Validated: >360 responses collected, >100 discarded when couldn’t be validated


The Paperless TMF: An Industry Benchmark

Sponsor 54%

CRO 20%

Consultant 9%

Site 13% Clinical

Operations 74% Records /

Info Mgmt 11%

Auditor / QA / QC

14%

IT 2%

Type of Organization n = 260

Functional Area

of Respondent n = 260

Site Mgmt

Organization

5%

Source: Paperless TMF – An Industry Benchmark, 2014


Initial Findings

Greatest barriers? cost, contracts, signatures, and

sites

Remote access for auditors will double in under a

year

Not all eTMFs are created equal

Sponsor-CRO collaboration is most paperless, but

still a long way to go

Priority metrics link data from TMF and CTMS

Emphasize that data is

hot off the press. There

are elements not yet

analyzed – specifically

slicing and dicing data by

sponsor/CRO, by big vs

small companies, etc.

More results will follow,

they should get a copy of

executive summary once

produced.


What’s keeping TMFs from going paperless?


11%

12%

13%

15%

17%

18%

18%

24%

26%

27%

32%

37%

Lack of interest/priority

CROs' requirements

Internal policies

Sites' requirements

Impact of organizational change

IRBs'/IECs' requirements

Uncertainty regarding regulatory changes

Limitation of in-house tools or technology

Lack of internal technical knowledge

Regulatory requirements

Cost of implementing new technology

Cost of new technology

Top Barriers: Costs and Wet Signature Requirements

To what extent is each of the following a barrier to TMFs going paperless in your organization? (n=260, Q.4)

Percent of respondents citing each as a major barrier or barrier that cannot be overcome.


Eliminate Un-necessary Signatures

SIGNATURE NOT REQUIRED

SIGNATURE REQUIRED

BY ICH GUIDELINES

Notification to Investigators of

Safety Information

Protocol signature page

(Sponsor and Investigator)

Regulatory Submission Contract with Site & Vendors

Monitoring Visit Report Site Delegation & Signature Log

Dose Escalation Documentation Case Report Forms

Trial Management Plan Regulatory Required Form (ex. Form

FDA 1572)

IRB/IEC Approval Signed Informed Consent Forms

All of which can be signed

electronically

Source: Lisa Mulcahy presentation, Designing Efficient Processes for TMF Content when Outsourcing Clinical Trials


20%

22%

25%

26%

33%

37%

38%

38%

43%

53%

Biostatistics

Data Management

Medical Science

Medical Writing

Drug Safety

Compliance/Quality Assurance

Regulatory

Clinical Records

Clinical Operations

Contracts

Top Departmental Barriers: Contracts Lags the Company

In each area, how many of your company's TMF docs are managed on paper at any point in their lifecycle? (n=260, Q.3)

Percent of respondents citing mostly paper or all paper.


Top Technical Barriers: e-sig, e-forms, Secure Access

Which of these capabilities do you think your organization needs in order to move to paperless TMFs? (n=260, Q.5)

Percent of respondents citing capability is needed to go paperless.

46%

47%

47%

55%

58%

62%

65%

66%

Integration with EDC

Integration with CTMS

Archival and export capabilities

Tracking and reporting

System compliance with regulatory reqs.

Secure access by external parties

Electronic forms

Digital or eSignatures


Shifting Perspective from Function to Process

Paper

Local

File

System

Cloud

File

System CMS eTMF

App

Electronic forms 82% 73% 67%

Digital or eSignatures 70% 67% 64%

Secure access by external parties 63% 63% 69%

System compliance with regulatory

reqs. 80% 59%

Tracking and reporting 78% 57%

Integration with CTMS 78%

Integration with EDC 63%

Which of these capabilities do you think your organization needs in order to move to paperless TMFs? (Q.5)

Percent of respondents citing capability is needed to go paperless.


Sites, IRBs/IECs Least Likely to Create or Collaborate on Docs Electronically

62%

56%

48% 47%

53%

43%

38% 36%

Internal staff Sponsor/CRO Sites IRBs/IECs

Electronic collaboration (exchange, QC, review, approval) with…

Electronic creation of source documents by…

To what extent is your company currently doing any of the following with TMF documents? (n=260, Q.8)

Percent responding Always/Mostly doing electronically.

IRBs/IECs are just as

likely to be working

with paper, but they

don’t account for as

many docs.


Remote access for auditors will more than double in under a year


Remote Access to More Than Double 33% of respondents are or will be providing auditors with remote

access to the eTMF in under a year.

22%

20%

12%

2%

11%

8%

10%

15%

I don't know

Have no plans

As soon as I have the technology tosupport it

More than 2 years

1 to 2 years

6 to 11 months

Within 6 months

Currently doing it now

18%

When, if ever, does your organization plan to provide auditors with remote access to trial master file documents? (Q.12)

Percent of respondents.


Remote Access for Auditors Most Likely if Using eTMF Application

37% 43%

29%

50%

18%

16% 10%

8%

9%

16%

Local FileSystem

Cloud FileSystem

CMS eTMFApplication

Paper


Percent of respondents citing currently doing, within 6 months, and within 6 to 11 months.


Disparities Lessen When Consider “As soon as I have the technology.”


Percent of respondents citing currently doing, within 6 months, and within 6 to 11months; as soon as I have the technology.

37% 43%

29%

50%

18%

16% 10%

8%

9%

16%

Local FileSystem

Cloud FileSystem

CMS eTMFApplication

Paper


Not all eTMFs are created equal


There is No One Type of “eTMF”

N/A [Paper] 18%

Local file system

25%

Cloud file share 17%

CMS 28%

eTMF application

13%

What type of TMF solution did you most recently use?

What type of eTMF solution did you most recently use? (n=260, Q.9)

Percent of respondents citing each.


Benefits Achieved with an eTMF

4%

22%

26%

31%

37%

38%

40%

40%

50%

65%

68%

None

Shortened clinical trial time

Easier collaboration with IRBs/IECs

Increased TMF SOP compliance

Better visibility into key trial performance metrics

Cost savings (from efficiencies, reduced…

Easier collaboration with sites

Improved audit and inspection readiness

Easier collaboration with CROs

Easier to search and find documents

Real-time tracking and viewing of documents

What benefits were achieved with your organization's implementation of the eTMF solution specified in Question 9?

(n=260, Q.10)

Percent of respondents citing each.


CMS/eTMF Apps Deliver Significantly More Benefits

4.0

5.1

Local / Cloud File System CMS / eTMF Application

Mean Number of Benefits Cited p =.005

What benefits were achieved with your organization's implementation of the eTMF solution specified in Question 9? (Q.10)

Mean number of benefits cited.

25% More


17%

25%

30%

28%

32%

43%

64%

68%

18%

15%

26%

33%

23%

59%

56%

59%

27%

44%

44%

44%

52%

48%

75%

71%

25%

31%

47%

47%

47%

56%

53%

72%

Shortened clinical trial time

Increased TMF SOP compliance

Better visibility into key trial performancemetrics

Cost savings (from efficiencies, reducedstorage, etc.)

Improved audit and inspection readiness

Easier collaboration with CROs

Easier to search and find documents

Real-time tracking and viewing of documents

eTMF App

CMS

Cloud File System

Local File System

Lesser Achieved Show Greater Variability

What benefits were achieved with your organization's implementation of the eTMF solution specified in Question 9?

(n=260, Q.10). Percent of respondents citing each.


Good/Major Improvements in Inspection Findings with eTMF

47%

50%

54%

56%

63%

65%

66%

Missing required signature

Suggested correction not done

Incomplete documents

Expired documents

Duplicate documents

Missing documents

Misfiled documents

How much improvement did you observe in the following inspection areas after your organization implemented the eTMF

specified in Q9? (n=260, Q.11)

Percent of respondents citing good or major improvement


CMS/eTMF Apps Deliver Significantly More Inspection Finding Improvements

3.8

4.8

Local / Cloud File System CMS / eTMF Application

Mean Number of Good/Major Improvements Cited p =.012


specified in Q9? (n=260, Q.11) Mean number of Good/Major Improvements cited.

26% More


Inspection Improvements by eTMF Type

Note that this isn’t the exact

same list as prior slide.

Incomplete documents isn’t

displayed b/c there was very

little variance in level of

improvement. I am showing

the six where there was

significant variance.

39%

41%

42%

52%

57%

52%

33%

45%

49%

57%

64%

57%

56%

57%

66%

64%

68%

66%

61%

56%

63%

85%

73%

84%

Missing required signature

Suggested correction not done

Expired documents

Duplicate documents

Missing documents

Misfiled documents

eTMF App

CMS

Cloud File System

Local File System


specified in Q9? (Q.11)

Percent of respondents citing good or major improvement


Sponsor-CRO collaboration is most electronic …but still a long way to go


The Collaboration Challenge

Source: Vantage Partners 2012 Sponsor Survey (81 Companies)

Sponsors reporting that

CROs are unable to work

collaboratively 48%

CROs reporting that

sponsors are unable to

work collaboratively 57%


Document exchange, QC, approvals between sponsors-CROs is mostly electronic

10%

30%

41%

15%

Paper SometimesElectronic

MostlyElectronic

AlwaysElectronic

To what extent is your company currently doing any of the following with TMF documents? Electronic collaboration

(exchange, QC, review, approval) on documents with CRO partners or sponsor clients (n=260, Q8) Percent of respondents.


Email is Primary Form of Document Exchange – But is Not Collaboration

15%

25%

29%

29%

43%

57%

68%

eTMF application (Veeva,NextDocs)

Fax

CMS (SharePoint, Documentum)

Cloud file share (FTP, Box)

Portal

Paper shipments (FedEx, UPS)

Email

What methods does your team use to exchange TMF documents with [Sponsor/CRO] external parties? Select all that apply

(n=260, Q2). Percent of respondents.


Structured Sharing Between Sponsor-CROs Evolves First

22 16

25

39

IRB’s/

IEC’s

Regulatory

Authorities

CRO/

Sponsor

Investigator

Sites

Portal

Paper shipments (FedEx, UPS)

Email

Cloud file share

CMS

eTMF application

Fax

What methods does your team use to exchange TMF documents with external parties? Select all that apply (n=260, Q2). Number of times cited by respondents.


More Likely Benefit in Sponsor/CRO collaboration with Cloud and eTMF apps

What benefits were achieved with your organization's implementation of the eTMF solution specified in Question 9? (Q.10)


43%

59%

48%

56%

Local FileSystem

Cloud FileSystem

CMS eTMFApplication

Easier Collaboration with CROs


Priority metrics link data from TMF and CTMS


Metrics Adoption is Low

Not collecting

data

Collecting data

but not using it

Using some

metrics to

improve process

execution

Extensively

using metrics to

improve process

execution

Extensively using

metrics to improve

process execution

and design

To what extent is your organization leveraging metrics or data to inform clinical trial processes? (n=260, Q.13)


16%

22%

42%

11% 9%


Metrics Adoption Differs By eTMF

Not collecting

data

Collecting data

but not using it

Using some

metrics to

improve process

execution

Extensively

using metrics to

improve process

execution

Extensively using

metrics to improve

process execution

and design

To what extent is your organization leveraging metrics or data to inform clinical trial processes? (n=260, Q.13)


eTMF Application

CMS

Cloud File System

Local File System

Paper

16%

22%

42%

11% 9%


Target Metrics Span TMF & CTMS Data Jen, I just noted that this

question asked for best

metrics w.r.t. shortening

clinical trials. In exec

summary or elsewhere may

want to look at connection

between the processes

identified and metrics

identified. Unfortunately the

metrics weren’t “write in”

and we didn’t call out

monitoring explicitly.

Let’s see whether we can

draw additional insights for

the bigger result summary

docs.

Which of the following metrics are, or would be, most useful in shortening clinical trials? Select up to five. (n=260, Q.14)


22%

23%

24%

27%

29%

37%

42%

43%

47%

50%

50%

Cycle time from quality check finding to resolution for TMFdocuments

Time from last site close-out to resolution of all quality checkfindings

Planned versus actual number of site initiations

Cycle time from first site initiation to interim analysis approval

Time from last site close-out to clinical study report approval

Cycle time from site identification to site selection

Number of protocol amendments

TMF quality (quality check findings and missing documents byorganization, site, CRO)

Planned versus actual number of subject enrollments

Cycle time from internal study approval to final protocol

Cycle times from site selection to IRB/IEC approval andIRB/IEC approval to site initiation


Target Metrics Span TMF & CTMS Data

37%

42%

43%

47%

50%

50%

Cycle time from site identification to siteselection

Number of protocol amendments

TMF quality (quality check findings and missingdocuments by organization, site, CRO)

Planned versus actual number of subjectenrollments

Cycle time from internal study approval to finalprotocol

Cycle times from site selection to IRB/IECapproval and IRB/IEC approval to site initiation




Target Metrics Span TMF & CTMS Data



22%

23%

24%

27%

29%

Cycle time from quality check finding toresolution for TMF documents

Time from last site close-out to resolution of allquality check findings

Planned versus actual number of siteinitiations

Cycle time from first site initiation to interimanalysis approval

Time from last site close-out to clinical studyreport approval


Next Steps – Benchmark Yourself Get the Survey


TMF Continuum Compare yourself with an industry benchmark

100%

Paper 100%

Electronic

Generation

Archiving

Processing

Current

53%

43%

70%

To what extent is your company currently doing any of the following with electronic TMF documents? (n=260, Q.8)

Percent of respondents indicating Mostly or Always Electronic.


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Initial Findings and Recommendations

Barriers: cost, contracts,

signatures, and sites

Remote access for

auditors to double

Not all eTMFs are created

equal

Sponsor-CRO collaboration

still a long way to go

Priority metrics link data from

TMF and CTMS

Explore cloud, re-evaluate

signature requirements

Create auditor “role” within

eTMF to control access

Consider greater benefit when

using CMS/eTMF application

Structure collaborative

processes within the eTMF

Develop metrics and

dashboards that draw from

eTMF and CTMS

Thank You Jennifer Goldsmith

VP, Veeva Vault

[email protected]

610-937-2859

welcome - veeva systems · ®2014 veeva systems – company confidential veeva.com | 10 initial...

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