Why the Industry Needs an EDM Reference Model DIA Webinar: EDM Reference Model Why the Industry Needs an EDM Reference Model DIA Document and Records Management SIAC

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Speakers and Panel Members Domain Michelle Herrera Foster Quality (CMC) Ken VanLuvanee Nonclinical John Aitken Clinical Lisa Mulcahy Trial Master File Sean Healey Administrative Jim Averback Cross-domain Features

Charter / Scope / Deliverables Project Chartered February 2007 Initial scope limited to documents intended for submission to regulatory agencies Deliverables From Charter: Guidelines and a preliminary model for a technology neutral electronic document management repository Applicable to creation and storage of documents Support the (e-)CTD and be open to future expansion Identify a minimum set of metadata

We Are Not Suggesting That this hasn’t been done already, many times by many companies Many solutions do exist Vendors have created solutions Companies have created their own solutions Like the “X” Files….solutions are “out there” but not always accessible , compatible and/or interoperable, i.e., content is not easily exchanged between systems

Beyond EDM – the TMF Reference Model Project Chartered March 2009 Scope: The full TMF with all applicable functional areas involved in clinical research. Not to include the preclinical, non-clinical, and chemical, manufacturing & controls functional areas. Deliverables From Charter: Definition of the TMF content by dividing into zones Defining standard nomenclature of the contents Defining options for TMF structure Integrate the TMF into EDM reference Model and definition of minimum metadata, including definition of new metadata, required for TMF contents

TMF Reference Model Global Reach European and USA co-chairs Pharma, Biotech, CRO, Health Service, IT companies Involving many functions: Clinical, document management, business development, regulatory, quality and compliance, data management, statistics, medical writing, pharmacovigilance, supplies and archiving Involving other Associations – QA, GCP, Clinical, Archiving, Data Management, Regulatory, other DIA SIACs Involving Regulatory Agencies The Need: People from any discipline that are passionate about the TMF and want to contribute to a global standard model

Why a Common Model? Economics / Technology Healthcare, Government, e-Health initiatives Integration of content from pharmaceuticals and healthcare Industry Mergers & Acquisitions Integration of content from different companies Externalization of Business Processes Exchange of content between companies Standards & Emerging Solutions CDISC, HL7 driving toward “computable” content CTD / e-CTD / NeeS / RPS

Why a Common Model? Industry Content taxonomy, i.e., the organization of content, is not a competitive advantage or a secret

Impact of Document Management Discovery to Post-Marketed Support Multitude of information sources “All roads lead to documents” EDM = expensive proposition if we constantly “re-invent the wheel” Lack of “throw away” models We have an opportunity to simplify and standardize EDM Save money, time and resources Leverage existing and emerging standards Ensure long term “findability” and Records Management

A Reference Model Not a requirement, but it does make life simpler and it is not hard if we work together

Freedom to Exchange Content Documents have multiple authors, contributors, and reviewers and increasingly from multiple companies Documents may be used in more than one way, by more than one organization Multiple submissions Possibly by multiple companies Multiple locations within a submission Due diligence for company or compound valuation

Efficiency and Cost-Savings Standardization for Contract Services Providers: Contract Research, Labs and Manufacturing Increased collaboration within and across industry Greater need than ever to share documents Compound in- and out-licensing Joint ventures Mergers and acquisitions Joint compound development and marketing

Submission-Ready Documents Documents can be organized and stored in ways that ease consumption and use Common, needed metadata can be associated with each document type Eases searching and inclusion in metadata-heavy formats Can assist Regulatory in initial assembly of commonly used submission formats …and can be extended for uncommon formats, as well

Adoption of Regulatory Standards Transition to eCTD The model provides recommendations on granularity for life cycle management RPS, NeeS and other CTD-based submission standards The model provides a stable core on which other standards can be layered Speed to adoption of new standards is facilitated by having a common model across the industry

Thank You to the Working Group Members Antoinette Azevedo Bonnie A Neuhardt Bridget Brayman Craig L Barrila Donald Palmer Edsel David Eric Makovsky Erick Gaussens Harv Martens JD Liddil Kimberly Ann Somermeyer Karen Roy Laura Sherman Lisa Grim Peggy Zorn Sean Healey Shuyen Huang Sophie Daniel Susan Landis Steve Scribner Thomas Altenwerth Tom Moore

Special Thank You The EDM Reference Model would not exist today were it not for the foresight and leadership of: Nancie Celini (CAB) John Aitken (Gilead Sciences) Dimitri Stamatiadis (Merck-Sorono)

Contact Persons Speaker Domain email Michelle Herrera Foster Quality (CMC) michelle@ctdquality.com Ken VanLuvanee Nonclinical ken.vanluvanee@apyx.com John Aitken Clinical John.Aitken@gilead.com Lisa Mulcahy Trial Master File mulcahy67@comcast.net Sean Healey Administrative Sean.Healey@pfizer.com Jim Averback Cross-domain Features averbacj@ls-integration-partners.com Leander Fontaine Labeling fontaine@pharmiceutics.com

How We Measure Success And Your Involvement! Your feedback Ongoing improvements Track record of implementation And Your Involvement!