trial master file summit - exl...

EXECUTIVE SUMMARY

www.exlevents.com/tmf

TRIAL MASTER FILE SUMMIT

4TH

TRIAL MASTER FILETRIAL MASTER FILE

Join the Conversation Group: Good Clinical Records Management

CONTENTS

INTRODUCTION 3

PRESENTATIONS 4

RESOURCES FOR INFORMATION AND DISCUSSION 11


3www.exlevents.com/tmf

INTRODUCTION

HERE’S WHAT YOU MISSED AT EXL PHARMA’S 4th TRIAL MASTER FILE SUMMIT

If you weren’t able to join us earlier this year, here is what you missed at ExL

Pharma’s 4th Trial Master File Summit …

With a focus on best practices to enhance TMF collection, monitoring, utilization,

quality and archiving while remaining compliant for audits and inspection readiness,

the only conference dedicated to paper and electronic TMF took place Jan. 21-23,

2015 in Arlington, Virginia.

The 2015 summit reviewed new and updated regulations from the MHRA, FDA, EMA

and PMDA while sharing what investigators are looking for to ensure the TMF is in a

continuous state of inspection readiness. Attendees also learned how to streamline

paper TMF to optimize security and global accessibility, training techniques to

ensure that staff keep the site running in an effective and compliant manner, and

how to overcome hurdles to eTMF implementation to reap the benefits of active

workflows to support study conduct and metadata knowledge management.

Further, the 4th annual event brought together professionals from pharmaceutical,

biotech, medical device, and clinical research organizations with responsibilities in

clinical operations, document management, regulatory affairs, TMF and eTMF, data

management, clinical document coordination, document and record specializations,

clinical development, regulatory operations, knowledge management, global

planning, clinical trial management, informatics and other areas.

As the largest meeting dedicated to the improvement of eTMF and paper TMF,

the Trial Master File Summit explored optimizing a TMF process to improve TMF

completeness, document, quality and efficiency.

Following are session summaries and highlights to give you an idea of what you

may have missed at our 4thTrial Master File Summit.


“Creating Cross-functional Teams for eTMF Implementation,” offered by Lisa Rakebrand

of Janssen Research and Development, focused on the company’s redesigned trial master

file processes and technology. Janssen started the process by building organizational

ownership with senior-level sponsorship and a steering committee as well as cross-functional

collaboration. Next, they identified TMF content and processes, updating the TMF SOP as

needed and familiarizing the organization with the TMF reference model alignment. System

configuration includes document types and attributes, lifecycles and workflows, roles and

security, reports, dashboards and templates. A TMF Center of Excellence was also initiated.

Team-building takeaways include the following: communicate and be transparent as often

as possible; tailor the message to the audience; identify your communication channels; be

aware of organizational structural changes; leverage technology; be honest with your team;

delegate; and have some fun along the way. Finally, empower the team with the ability to

make decisions and move the transformation forward.

“Leverage eTMF to Improve Monitoring and Inspection Readiness through Advanced

Rendering,” delivered by John Hanrahan of Adlib, explained that advanced rendering

automates the conversion of corporate documents and intellectual property into accessible

and usable digital assets that streamline document-intensive business processes. This

improves collaboration, increases overall efficiency, mitigates risk and reduces costs. Convert,

combine and enhance are the keys to creating the perfect, compliant PDFs. Likewise, email

capture, process and archive involves content discovery and clean-up, migration to ECM

repository and converting emails to PDF. Document attributes can influence and impact

compliance, in particular, fidelity, navigability, findability and security. A special PDF checker

can check any PDF for compliance issues, automating manual publishing quality control steps,

identifying pages that require attention and saving the report as a non-PDF ECM rendition,

among other features.

PRESENTATIONS


Shannon Cooke of TransPerfect shared “ETMF and Site

Archiving: Perspective, Case Studies, Lessons Learned” with

a wealth of solutions for going paperless. Pharma and drug

development groups are becoming more comfortable with

e-submissions and eTMF, supported by business drivers such

as increased employee and site performance, decrease in

study start-up timeliness, increased transparency, reduction in

hard costs and increased study collaboration.

Key eTMF site benefi ts include workfl ow effi ciencies,

streamline versus redundancy, transparency and assurances,

and access to information. Connecting with patients is also

important – sites are fi lled with busy people and increasing effi ciency and decreasing stress

is a signifi cant benefi t. This can include e-submission via portals, dashboards of relevant

information, auto-generated notifi cations/task management, and greater transparency

and visibility. The main reported concern is that the site staff doesn’t have the technical

profi ciency to use the eTMF effi ciently. It’s important to select an integrated platform that

connects feasibility, study start-up and eTMF and to ensure that it can share data across the

process steps. Practical site tips include: keep updated e-versions of all frequently requested

documents, be proactive and continuing education for site staff. For sponsors, get started

early and stay ahead of the curve while offering continuing education for staff.

Sukh Chugh of Allergen presented “Building an Investigator

Portal from the Ground up: Decisions, Pitfalls and Lessons

Learned,” in which Allergan decided to build its own investor

portal. They wanted to articulate long-term vision, develop

a catalog of needs, prioritize areas of functionality, contract

external vendors to assist, manage culture change, pilot to

show early success, incorporate lessons learned and reinforce

the vision. The prioritized areas of functionality were single

sign-on, training system integration, CTMS integration,

document repository integration, study start-up document

exchange and digital signature.

The solution was an investigator portal – a web-based tool that would act as a single source

for clinical trial interactions between Allergan and clinical sites; it was built on SalesForce

Platform, combined with various partner capabilities and resulted in extensive effi ciencies.

Lessons learned centered around international requirements, data accuracy, scale to effi ciency,

change management, site adoption, ongoing senior management support, UI for internal users

and the need to watch for additional costs.

SALESFORCE.COM

(Gatekeeper)

(Template Autofill)

External Interface

Internal Interface

(WebService)

OKTA

DOCUSIGN (21CFR Part 11)

CONGA

THE BUSINESS DRIVERS BEHIND IT . . . .


Jason Methia of Veeva helped attendees with “Establishing

Processes and Controls to Ensure an Inspection-Ready

TMF Every Day,” noting that 35 percent of inspections over

the past year resulted in extra days of inspection based on

difficulties with TMFs being complete and readily available.

The paper legacy holds back productivity and inspection

readiness while multiple divergent systems impact compliance.

All of this means that there is significant opportunity for

the industry: only half of electronic models use eTMFs with

advanced process management. The TMF maturity model

for life sciences incorporates TMF strategy, infrastructure,

process alignment, collaboration, compliance and governance. Technology, then, can bring

together sponsors, sites and CROs. eTMFs offer cost savings, improved audits and improved

SOP compliance. Creating an inspection-ready compliance model involves three keys stages:

1) evaluate all aspects of TMF operations; 2) push towards single source of truth environment;

and 3) shift from passive eTMF archive to active eTMF application.

A panel discussion on how to “Create, Utilize and Enhance Your TMF Process through Metrics

Implementation” was hosted by Linda Sullivan of Metrics Champion Consortium, Vinita

Leslie of Biogen Idec, Terri Thomasma of Abbvie, Ivan Walrath of Pfizer and Nancy Snowden

of NGCG. Each panel member shared brief information about their companies and roles,

including details on understanding the process improvement metrics has on YMF collection

and monitoring and the importance of implementing metrics in reforming key performance

indicators.

For example, Biogen Idec has a team called KRIS: Knowledge, Records and Information

Strategies. This global team within regulatory affairs focuses on knowledge management,

records and information management, collaboration and best practices. They use two sets

of metrics – study centric and eTMF centric. The company provides reports with consistent

information, focuses on areas of non-compliance and limits metrication to a level sufficient

to demonstrate compliance and then handles non-compliance on a case-by-case basis.

Furthermore, NCGS focuses on quality processes, eTMF and support services with enterprise-

wide eTMF owners and team leads as well as well-defined QC/QA processes end to end. All

members encouraged the implementation of a global metrics and monitoring platform.

®2015 Veeva Systems – Company Confidential veeva.com | 8

Significant Opportunity for the Industry

What type of eTMF solution did you most recently use? (n=135, Q.9) Sponsor company responses only.

13%

26%

18%

30%

13% N/A, only use paper

Local file system

Cloud file share

Content mgmt. system

eTMF Application

Only half of electronic models use eTMFs with advanced process management

Source: Veeva 2015 Paperless TMF Survey


“eTMF Migrations: Key Considerations in Determining the Right Approach for Your

Organization” from Kathie Clark of Wingspan Technologies focused on moving beyond TMFs

stored in a vanilla SharePoint or Documentum system and defi ning goals of the migration.

What can go wrong? Scope creep, too much user time, missing information, poor return

on investment and more. Understanding the business goals of the eTMF migration helps

companies make the right choices when presented with diffi cult decisions; organizations have

more latitude in defi ning the scope of their eTMF migrations than with other migrations. A

set of specifi c requirements and a project plan will help promote scope control and deliver

results on time. The quality of the document content and metadata for migrated documents

depends on the quality control practices that were in place for the legacy systems. If the level

of confi dence in content and metadata is not high, further quality control may be justifi ed

and needed before documents are made available for use in the eTMF. As with most aspects

of migration, a risk-based approach is recommended. After migration decisions are made,

a fi nal review of the cost and benefi ts should be done to identify decisions that may have

inadvertently added signifi cant scope and cost to the migration effort.

A case study on “Understanding the Latest Regulations and

Guidance and Preparing for Inspection,” delivered by Ivan

Walrath of Pfi zer, explored trends in regulations and discussed

the TMF as critical to regulatory and legal compliance. The

future approach may involve remote access for inspectors

– which could reduce the number of days on site as well as

the costs associated with regulatory inspections. Meeting

regulatory requirements involves the documentation necessary

to reconstruct the conduct of trials in accordance with

standards of ICH, GCP and using the DIA TMF reference model;

Pfi zer developed a comprehensive master TMF document list

to meet specifi c European standards. An interactive metrics

function allows users to monitor outcomes and take control of the TMF process – three

measures (TMF document quality, completeness and timeliness) help to ensure the highest

standards in the TMF. The company also sets standards for transparency and full disclosure.

9

A Readily Accessible Interface for Regulatory Inspections

Document Owners eTMF Repository Inspectors and Pfizer Colleagues

Document Owners eTMF Repositories Inspectors and Pfizer Colleagues

9

Before

Today

Setting standards for transparency and full disclosure

A simple view into the TMF; simple, hands on accountability


Karen Roy of Phlex offered the latest information on “The

Trial Master File Reference Model: The Road to Version 3,”

noting that the TMF Reference Model was created through a

group of Drug Information Association volunteers with about

350 contributors from about 200 companies. Goals of the

reference model are: standard contents, standard naming,

standard structure and standard metadata, all intended to

bring therapies to market faster. In a survey, most companies

have used it and the majority have modifi ed it somewhat.

Challenges of moving to version 3 are overall coordinator

time, zone lead time, zone members’ engagement, collating

feedback in a standardized format, standardizing review

process per zone and collections of documents vs. single

documents against an artifact. There are 11 zones, each with

a team leader. Inputs and deliverables include consolidated

public feedback for each zone and responses to that feedback,

applicable cross-zone issues for resolution, marked-up zone

content and clean content. A technical committee also works

on the reference model, making it usable and understandable

in more formats. Finally, a communication team provides

regular updates and manages publications and social media.

“Develop an eTMF Mentality by Innovating Paper TMF Processes” from David Benedit and

Eric Rubinson of Actavis shared the Forest Research Institute’s approach for creating an eTMF

mindset by integrating the look and feel of eTMF into current paper processes, including case

studies of six process improvements. Business objectives for embracing eTMF include the

desire for electronic records, virtual processing and remote reconciliation, electronic approvals

and submission, elimination of redundancies and real-time transparent operations. A phased

and incremental approach involved collaboration and pilot studies as proof of concept.

Centralized transmittal tracking led to notable benefi ts, such as predefi ned metadata and

reduction in redundancies. A centralized mail depot signifi cantly strengthened the security,

oversight and throughput effi ciency of paper records bound for the TMF.

They also developed a SharePoint tool that allows regional site monitors to submit approved

visit reports electronically and track archival status in the TMF; this reduces shipping

administration/costs, takes less time than completing an air bill, turns transmittal form details

into a real-time searchable table of contents, builds on naming conventions and metadata

standards for future eTMF, and the platform is eTMF ready with appropriate validation. It

looks and feels like eTMF but facilitates the current paper process. Continued results include

signifi cant savings and improved process satisfaction.

}  104 responses


A Boehringer-Ingelheim case study on “How to Achieve the Best Results in Document

Submission from a CRO” was shared by Fabio Rodrigues, clinical manager of the company’s

Medical division. His key suggestions were to work regionally with CROs in LATAM and

discuss expectations; identify and develop strategic KPIs; and increase communication

through executive meetings with upper management from CRO to share results. The company

outsources most clinical trials to CROs in LATAM and needed to evolve process flows to save

time and money.

Measurement leads to control and then to improvement and KPIs were established for metrics:

KPI1 with eTMF monthly document submission; KPI2 was eTMF quality check; and KPI3 was

eTMF completeness. Building a partnership involves following up with the CROs activity on a

regular basis and developing an eTMF action plan. Other lessons include: make expectations

clear to everyone; establish easy metrics to measure because they encourage the CRO to

achieve the best results; keep track of the work; and collaborate for success.

“Effective CRO Oversight to Ensure Compliance and an Up-to-Date TMF” from Wendy

Trimboli of Eisai noted that effective communication is one of the chief keys to maximizing

efficiencies, quality and oversight. She suggested interacting with one point of contact at the

CRO and conducting quarterly oversight meetings. It is also important to manage the flow of

trial information between sponsor and CRO and to utilize a standard list of SOPs. Automated

processes, system integration, a complete TMF, quality control reviews, metrics and a focus on

continuous improvement are additional keys to success.

Issues and lessons learned include: many issues are reported from multiple sources so the

company created an issues log spreadsheet to identify issues, trends, source, QC check and

more; there is a strong need for transparency so queried documents are now viewable within

the system and shared with CRO contacts; continuous improvement assessments will lead to

process improvements.


A case study on “How to Maintain a Compliant TMF across Multiple Global Sites” was shared

by Andrew Waite of Amgen, who encouraged organizations to stay organized during set-up,

maintenance and archiving for outsourced studies while establishing communication with

international clinical sites. The Amgen case study involved multiple Ph3 studies full service

outsourced to CROs, inclusive of TMF management. Challenges were that CRO SOPs and the

process utilized for study conduct did not fully match Amgen’s TMF structure and process and

TMF files were decentralized management. Amgen introduced a new eTMF solution where

the files were available online 24/7 globally for non-outsourced studies and an expectation

was set that all TMF documents would be accessible anywhere and anytime – now program

managers wanted the same access for outsourced programs. A decision was made to bring

in-house all outsourced TMFs and place them into the new Amgen eTMF system. Top-notch

organization and communication helped the company navigate set-up as well as cultural,

lingual and time-zone differences. In conclusion, he stressed the importance of defining the

TMF process upfront to ensure accountability and reminded audience members that the TMF

world continues to evolve. He finished by defining TMF as Too Much Fun.

“So You’re the Little Guy: Achieve TMF Inspection Readiness,” which was presented by

Curran Murphy of Cerulean Pharma, stated that “even though you’re small/a start-up, you

can achieve TMF inspection readiness.” It is all about the planning: Know your organizational

structure, define TMF structure and process, and execute with internal quality oversight.

Getting started entails assembling a TMF sub team with good facilitation, timelines and

ongoing progress reporting. This team will define organizational structure, TMF gaps and TMF

structure – a quality representative is also part of this process. TMF process tools for the small

company include the following: a TMF plan template, TMF structure set-up checklist, TMF

structure change checklist, TMF inventory template, periodic quality check template, close-out

quality check template and authorization to ship TMF. Finally, periodic quality checks are the

best insurance for inspection readiness.

“This was a great conference overall and incredibly informative” - Associate Director, SSU Regulatory, INC Research

“Fantastic speakers and session” - TMF Records Management, ELI LILLY

“Especially liked the actual case studies and I appreciate when vendors present new tools and technology.”- Senior CTA Clinical Systems, ALKERMES

“Excellent overview of events from the past year and why we are here...valuable lessons learned.”- Senior Project Manager, GSK


RESOURCES FOR INFORMATION AND DISCUSSION

At ExL Pharma’s 5th Trial Master File Summit, TMF experts will discuss best practices for developing,

managing and monitoring a TMF process that is regulatory compliant for audits and inspections. TMF

process owners, quality assurance, clinical, regulatory and information technology professionals who

are responsible for Trial Master Files will share insights and best practices to facilitate successful TMF

management.

For more information or to register for the 2016 event please visit:


If you are interested in sponsorship or exhibition opportunities please contact Eric Morrin at 212-400-6228

or [email protected].

January 20-22, 2016 / The Westin Arlington Gateway / Arlington, VA

TRIAL MASTER FILE SUMMIT

Develop a TMF process in order to ensure a complete, compliant, high-quality and inspection-ready TMF

THE INDUSTRY’S ONLY CONFERENCE SERIES DEDICATED TO IMPROVING PAPER AND ELECTRONIC TMF MANAGEMENT

5TH

TRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILETRIAL MASTER FILE

20 educational sessions covering all aspects of paper and electronic TMF filings

6 case study presentations from Amgen, Bayer, BioMarin, Boehringer Ingelheim, Eisai and Janssen

A TMF workshop for newcomers, which introduces the Trial Master File and the many challenges that TMF professionals face

A 5-hour interactive TMF training seminar on the keys to successful TMF management

9+ hours of networking with 175+ TMF professionals

An engaging panel session on trends, the preparation of and expectations for a TMF inspection

14+ hours of educational sessions that will provide you with best practices, lessons learned and case studies

Updates on the DIA Reference Model Version 3.0, TransCelerate’s eISF and the MCC’s working group

THE 2016 TMF SUMMIT FEATURES:


Website: http://www.arivis.com/en

Website: http://www.lmkclinicalresearch.com/

NCGS, Incorporated, an international CRO, leverages integrated technology to mitigate risk

and provide agile management.

SERVICES: Trial, Grants, and Data Management; eTMF, CTMS, EDC, ePRO, IWRS, RBM; Full or

Strategic Sourcing; Trial Rescue.

RESULTS: Approval or expanded labeling of 31 products in 31 years of operation; Zero 483s.

WBENC Diversity Certified.

Website: http://www.ncgs.com/

Phlexglobal are the Trial Master File (TMF) Experts, and pioneers in the provision of

innovative, flexible and technology-enabled TMF solutions & services.

A specialist provider of electronic Trial Master File (eTMF) solutions and other support

services to the global clinical research market; we offer a unique combination of technology,

quality and services that deliver a range of flexible, targeted solutions to the life science

industry.

Website: http://www.phlexglobal.com

Rho, a full-service CRO, has been a trusted partner to leading pharmaceutical, biotechnology

and medical device companies as well as academic and government organizations for 30

years. Our commitment to excellence, innovative technologies and therapeutic expertise

accelerate time to market and lead to an exceptional customer experience.

Website: http://www.rhoworld.com/


T r u e e - I n t e g r a t i o n . A s i n g l e p o r t a l .


TransPerfect provides a collaborative Web-based platform for study start-up and eTMF that

enables sponsors, CROs, IRBs, central laboratories, and other vendors to maintain and update

clinical trial documentation in a secure online environment. TransPerfect’s Life Sciences

division is dedicated to working with clients on a global, collaborative level, supporting a

wide range of requirements including product licensing and alliance management, endpoint

adjudication, eTMF review/reconciliation, and pharmacovigilance.

Website: http://www.transperfect.com/

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry.

Committed to innovation, product excellence, and customer success, Veeva has more than

300 customers, ranging from the world’s largest pharmaceutical companies to emerging

biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia,

and Latin America. For more information, visit www.veeva.com.

Global life sciences companies worldwide rely on Veeva Vault eTMF to managing their TMF

documents and processes. Designed specifically for the life sciences industry, Vault eTMF

not only lets you create, exchange, and update all of your trial documents within one secure,

cloud-based application, it also supports your trial processes across all of your partners. To

learn more about Vault eTMF, visit: https://www.veeva.com/products/rd-cloud/vault-etmf/.

Website: http://www.veeva.com

Wingspan Technology, Inc. provides an industry-leading cloud-based eTMF to both sponsors

and CROs. eTMF provides a modern user experience modeled on commercial websites

such as Amazon and eBay – dramatically reducing user training time and frustration. Our

dashboards and metrics provide unprecedented insight into the status and health of ongoing

trials. Simple processes for uploading and checking documents greatly decrease both

the time needed for these processes and the possibility of error. Our robust and scalable

infrastructure has a proven track record of supporting users in more than 60 countries

worldwide in processing up to 10,000 documents a day for hundreds of trials.

Website: http://www.mywingspan.com


W i n g s p a n ™Technology, Inc. W i n g s p a n ™

Technology, Inc.

CMYK

W i n g s p a n ™Technology, Inc.

W i n g s p a n ™Technology, Inc.

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