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 Discovery Future State Requirements Findings Rollout

 Identify the  Statement of  Define  Define Guiding  Validation of

Critical Success goals Implementation Principle findings
Factors Plan & Roadmap
 Requirements  Freeze  Recap & Sign-
 Define Project collection  Develop Conceptual off
Charter Governance & Design
 Interviews and
 Expectation Operation model
workshop sessions
setting
 Work plan
preparation
 What we bring to the table… What does it mean to you…
Business Consulting Service Best fit between Business & Technology

Contributes 10% to corporate topline

High quality strategic design
Defined business characteristics of CDISC based
Streamlined flow of industry best practices
next generation Clinical Data Management
Application
CDISC & Clinical Expertise Qualified Partner
Thought Leadership provided in industry


forums – FDA Science Congress, CRO Knowledge of your industry and why this project is
Congress, DIA, CDISC taking place
 Invested to create data standards for Access to the information asset (Mapping methods
UNPUBLISHEDRESERVED CDISC Domains & for Oncology & Vaccine) & Data Standards for
Specialized Therapeutic Areas – Oncology & CDISC Domains
Vaccine
 Significant
Qualified Team EDC & CTMS
– Industry Experience
Practitioners Knowledge Driven Project Team

Prior experience in delivering these solutions by

Defined CDISC standard and adoption strategy in
the proposed team
Pharmaceutical Company
Proactive identification & escalation of issues and
Chairperson of CDISC Implementation Committee
perceived risk
Complex & Large Implementation Experience Less Risk & Reduced TCO
 One of the 1st Janus / CDISC Implementation Project specific knowledge retained during the
 Implementation of factory based approach for implementation
Clinical Trial Data Migration Reduced TCO