Ppt Database 51

Using the time-to-market calculation, a life science manufacturer that achieves a 1 percent improvement in the clinical trial process would see a financial benefit of $5.1 million. - ABC

Project Initiation  Identify the Critical Success Factors  Define Project Charter  Expectation setting  Work plan preparation

Discovery

 Statement of goals  Requirements collection  Interviews and workshop sessions

Future State

 Define Implementation Plan & Roadmap  Develop Governance & Operation model

Requirements

Findings Rollout

 Define Guiding Principle

 Validation of findings

 Freeze Conceptual Design

 Recap & off

Sign-

What we bring to the table… Business Consulting Service Contributes 10% to corporate topline Defined business characteristics of CDISC based next generation Clinical Data Management Application CDISC & Clinical Expertise Thought Leadership provided in industry forums – FDA Science Congress, CRO Congress, DIA, CDISC  Invested to create data standards for UNPUBLISHEDRESERVED CDISC Domains & Specialized Therapeutic Areas – Oncology & Vaccine  Significant Qualified Team EDC – Industry Practitioners & CTMS Experience

What does it mean to you… Best fit between Business & Technology High quality strategic design Streamlined flow of industry best practices

Qualified Partner

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Defined CDISC standard and adoption strategy in Pharmaceutical Company Chairperson of CDISC Implementation Committee Complex & Large Implementation Experience  

One of the 1st Janus / CDISC Implementation Implementation of factory based approach for Clinical Trial Data Migration

Knowledge of your industry and why this project is taking place Access to the information asset (Mapping methods for Oncology & Vaccine) & Data Standards for CDISC Domains Knowledge Driven Project Team Prior experience in delivering these solutions by the proposed team Proactive identification & escalation of issues and perceived risk Less Risk & Reduced TCO Project specific knowledge retained during the implementation Reduced TCO