Transforming a Paper‐Based Trial Master File to a Streamlined Electronic Document Management Solution

A European Pharmaceutical Review Webinar

Patricia Brady, Senior International Clinical Trial Manager, SanofiGuillaume Gerard, Senior Director, EU Services, NextDocs

AegerionAlexionAlkermesAmicus Therapeutics AptivArizona ChemicalAstra ZenecaBecton DickinsonBialCovanceDuke Clinical ResearchFocus SurgeryGalderma

OncothyreonParRegeneronRentschler Biotech SandozSanofiSanofi Pasteur MSDSantenStanford UniversityThermo Fisher ScientificTelerxVaccinex

IDT BiologikaKIKLeica MicroMcKessonMeda PharmaMMSNapp PharmaNational Cancer Center (Japan)NektarNovaNovella ClinicalNPS

0%

10%

20%

30%

40%

50%

60%

70%

80%

General DocManagement

Project TeamSites

CompanyIntranet

KnowledgeBase

Management

SOP/Training RecordsManagement

CAPA/Deviations/

ChangeControl/

Complaints

Clinical TrialDocs (TMF)

FDASubmission

Docs

Clinical TrialActivities

Help Desk

Where do you use SharePoint today?2012

2013

Source: NextDocs SharePoint for Life Sciences Survey2012: 110 responses2013: 137 responses

All trials, 9%

Some clinical trials, 26%

Implementing, 11%Evaluating, 22%

Have not decided, 19%

Decided not to use, 13%

Where are you using an eTMF solution?N = 60

Source: NextDocs State of eTMF Adoption Survey 2013

Metrics for success

75% increased productivity and/or utilization

44% reduced time to prepare for study milestones and events

40% improved audit results

• It began with the use of EDC• New methodologies for moving new drugs to the market place

• No more blockbusters ‐ heading in a new direction of personalized medicine

• Pharma is moving from industry of products to one that manages information (patient data)

• MHR initiatives 

What drove the Industry Towards Collaboration?

Key Business Drivers

• Shrinking Pipelines• Attrition rate for molecules are high• Therapeutic areas are being commoditized• Driven to in‐license • Forced to develop more truly innovative compounds• Pressured to continue internal development as well as work with small biotechs and academia

Outcome of These Industry Changes…

• Data in disparate locations• Data distributed both internally and externally• Hence, driving the industry needs towards:

Where We Began…. •Realized the Critical need for a Validated Repository •Transition from Paper to electronic ASAP•Centralized storage of ETMF Documents•Visibility for OperationsEfficiency  depends upon our ability to change•Design and implement optimized processes •Ensure Accountability for completing and compiling our  eTMF •Remove duplicity and focus on quality

What We’ve Achieved….• One common platform that 

enables all stakeholders (internal and external ) the level of transparency needed

• A tool that has provided   global vision and insight of eTMF collection and trial milestone progression.

• Ability to present information that visually can demonstrate factors related to KPI’s  

Study managem

ent

eTMF

Portal

CWP

« Collaboration

web Portal »

Web conferenc

e

User & sites profile

Collaboration

Communication

The Road to Success:

Select Countries

Feasibility Surveys

(Trial, EDC)

Select Sites / Investigators

Budget & Contract

Negotiation

Collection of 1572, CV, Financial

Disclosure, etc.

Electronic Data Capture (EDC)Interim safety

reviews, queries, drill-down reports

Training & Investigator

Meetings

IWRS Integration, Drug Shipment & Reconciliation,

Patient Visit Schedules

Site Personnel changes, lab licenses, etc.

(ongoing)

Finalize Recruitment

Materials with Sites / IRBs

Collaboration Portal

Outstanding Items, Calendar, Messages/Alerts,

Enrollment Performance

IRB Approval Documentation

Dear Investigator Letters, newsletters,

communications

Clinical Team Documents

Payment Detail

Reports

Study Library (key reference

documents)

Contact Management

Study Planning & Management (CTMS)

Study Start-Up

Study Execution

Potential Investigator Registration

New Trial Information

Sponsor Activities Only

Collaboration, Study-Specific Tools, Other

eTMF / Documentum

Site / Partner Activities with

Sponsor support

Potential Investigator

Activities

Documents Support Trial Milestones

Clinical Trial Start Up

FPFVES Protocol CTA

IP Available

FDF

1572

Confidentiality Agreement

Areas in which Clinical Trials need Process Optimization:

• Oversight and collection of quality ETMF documents• Visibility into Regulatory Start‐Up processes

• Including 1572’s, CV’s, Protocol Signature pages, Insurance certificates, Informed consents etc…….

• Document submission tracking to Regulatory Agencies• Visibility and oversight to properly manage ERC/IRB, Health Authority submissions/Approvals

• Ability to produce timely packaging and release of drug supplies. • Shortening duration from Protocol Approval to First Patient 

Randomized!

What is needed for IP Greenlight?

Regulatory Authority Submissions• Varies per country• Notification/Approvals of 

protocol and sites• Forms• Documents• Import Licenses

ERC/IRB Committees Submission

Clinical Ops• Varies per country• Central/Local• Approvals of Prot/ICF• Committee Approval 

documents

Sponsor Manufacturing Documents• COA• IMPD• QP release• Safety Data Sheets• Batch records• Labeling• Packaging

Regulatory Package ApprovalRegulatory Green Light Technical/Manufacturing Green Light

DRUG Released to Investigative Sites

Forms Integration

• Ability to drive data from collection into other systems‐data visualization and dashboard metrics

• Drives Cross Enterprise Collaboration due to multi‐functional area involvement (Triggering cross functional processes across the organization)

• Less manual intervention• Less duplicate data entry• Less Error prone data• Data at the point of origin less transcription errors

Auditing View‐ Inspection Ready

• Metadata tagging for documents that are commonly recalled as part of an audit 

• Ability to create auditing specific views

• 80% of the eTMF volume created by 20% of the eTMF Document types

• Ensures the inspection Readiness of your organization

Applied Features and Functionality

Driving Operational Excellence

•Dashboard Capabilities

•Centralized Reporting

•Document Libraries

•On line – Drug Reconciliation

•Web based Forms•Enterprise Doc Management•Regulated Records•Version Control•Alerts/ Notifications•Edit Checks

•Digital Signature

•Workflows/ Search/ Retrieval

Clinical Trial PortalHigh Level Roadmap

Communications: Implement a module for alerts / messages, news, Calendar, FAQs, etc.

Clinical Task Enablement I:

Implement Patient Visit Schedules and integrated Drug Shipment / Reconciliation Logs

Feasibility Surveys & Potential Investigators: Enable Site Feasibility and RDC Feasibility Surveys for Potential and Existing Investigators

Trial Status: Create Dashboard with Critical Alerts, Site/Study Milestones, Enrollment Metrics, CTI Reports, etc. (integrate “What’s Missing”)

Workflows:

Continue to Streamline Processes, update SOPs, create Workflows for all remaining Documents

Infrastructure: Build the Foundation within Sanofi-Aventis, begin path to SSO

Security: Design the Security Model, Identity & Access Management and Profiles

eTMF Model:

Define eTMF Governance Model, Guiding Principles and Taxonomy

Document Management: Pilot & Implement Document Exchange capabilities (Workflow, Signatures, Search, etc.)

Document Status: Provide Status Views of TMF Completion, Outstanding Documents / “What’s Missing”

Workflows:

Streamline Processes / SOPs, create Workflows for initial Documents

Payment Detail: Provide Study Payment information, including detail reports with Subject ID / Visit identifiers

Wave II: Improving Investigator / Site Relationships & Performance

Wave III: Maturing the Capabilities

Wave I: Building the Foundation & Gaining Confidence

Clinical Task Enablement II:

Integrate with IWRS Vendor systems

Site Selection:Develop tools to

review surveys /

inputs to generate,rank and share

draft Site

lists

Additional Capabilities:Implement

additional features as prioritized (e.g.,

Lifecycle Management)

18

•…

CPL

19Copyright © 2012 Accenture All Rights Reserved.

Operational Model

OWNER (Document author)

OWNER (Document author)

Reviewer(s)*Reviewer(s)*

Approver(s)*Approver(s)*

2. Document CONTRIBUTORS2. Document 

CONTRIBUTORS

*For documents being created in a lifecycle

+1. Document METADATA1. Document METADATA

CountryCountry

LifecycleLifecycle

Etc…Etc…

Section < Sub section

Section < Sub section

PI CVPI CV

Form FDA 1572Form FDA 1572

3. Document LIFECYCLE

3. Document LIFECYCLE

StandardStandard

Financial DisclosureFinancial Disclosure

Monitoring PlanMonitoring Plan

+

= A document in the Clinical Trial Portal is defined by metadata, contributors and a lifecycle. 

A new generation of eTMFKey concept (1/2)

20Copyright © 2012 Accenture All Rights Reserved.

A new generation of eTMFKey concept (2/2)

Missing documents linkDraft documentsFinal documentsExcused documents

Study creation

During study

End of study

CEPPhase I Onco

Phase II‐III

CEPPhase I Onco

Phase II‐III

Master eTMF Library

Local eTMF Libraries

Country 1 Country 2 Country 3

TEMPLATE workspace

Master

Local for Country 1Local for Country 3

Clinical Trial portal

Study code, list of countries, list of sites

CTMS

Study information

User accountsList of accounts authorized for a selected study

IAM

Study LibraryStudy workspace creation

eTMF completion secured

CRAeTMF

Investigators Regulatory

Clinical Manager

21Copyright © 2012 Accenture All Rights Reserved.

Clinical Trial Portal at a glanceA single homepage …

A link to all your study workspaces

My applications A link to your clinical applications (e.g. eCRF, Impact, etc.)

Help An access to user guide and Support contacts

A single homepage with an easy access 

studiesMy current studies

Training Corner An access to your training materials for the Portal

Digital Signature verifier

A link to install sanofi‐aventis certificate of your digital signature 

Home page

Prerequisites to get access to your study(ies)

22Copyright © 2012 Accenture All Rights Reserved.

Clinical Trial Portal at a glanceStudy workspace

23

“Study home” is the study homepage displaying key study information,  including to‐do list and “my applications”, working area

“Study documents” contains all study documents including eTMF

“Study news”displays both global and local news

“Study contacts”contains the list of contacts imported from IMPACT and manually entered

“Study milestones”displays essential milestones like First Patient First Visit or Database Lock dates.

One study workspace is created per study.  They will be personalized with data coming from CTMS.

Study workspace

Examples of views & metadata

Allowing filtering & sorting of documents

Section Sub‐section Study Milestones Country LifecycleDocument Name

Clinical Trial Portal at a glanceViews & metadata

24

Document features : contributors

There is one check‐list per study role (document owner according to SOP), which displays missing and created documents

Available Checklists Missing and created documents are displayed : 

This icon means the document is missing. A click on the link will launch the eTMF Wizard

The Word icon means the document is created. 

Etc.

Clinical Trial Portal at a glanceChecklist & missing documents

25

<<Your Logo>>

27

Visit www.nextdocs.com

See a demo of a clinical portal implementation

“The Seven Elements of a Clinical

Collaboration Platform”

Learn more about eTMF and Clinical

Portal Uses

“Sanofi Expects Online Collaboration to Save

Millions of Euros”