Business Process Integration

Describes post-merger business and systems integration from a process point of view. Paper developed for and published in "Bâtisseurs d'Alliances" by Jean-Pierre Guth.

Your Systems Project is not a Systems Project

The 10 "DOs" in Selecting and Implementing Innovative Information Technology. Presented at the DIA Annual Meeting, Baltimore.

Readying Business Processes For Major Systems Rollouts

Purchasing and implementing large scale information systems like a sophisticated global Patient Data Management Systems is in itself not enough for meeting business needs. The business processes which the system is meant to enable must be defined by the business, against clearly defined objectives. This presentation offers a brief synopsis of what it takes to get business processes ready for a seamless transition using Oracle Clinical as the case study. Presented at the Oracle Clinical Global User Conference, Paris, France.

Introduction to Quality Gates

An introduction to the PROsys Quality Gates Method. A requirements-based approach to making Quality in the Process as manageable as Time and Cost.

Generating Business Value through Information Systems

Demonstrates the PROsys Business Process Framework as it applies to Pharmaceutical Research and Development. Developed for and published by the DEC Industrial Expertise Center.

Risk Based Clinical Quality Assurance

Approach, challenges, and learnings of implementing a risk based approach to clinical quality assurance in the pharmaceutical industry. Presentation at the Organization of Regulatory and Clinical Associates in 2006.

Developing IT Business Solutions in a Regulated Environment

Illustrating the relationship between the lifecycle of growing biotech organizations and the IT business solution needs. Presentation at the Organization of Regulatory and Clinical Associates in 2005.

Implementing Technologies - It is not a Systems Issue

Implementation Issues of Electronic Data Capture (EDC) Technologies in the Pharmaceutical Industry. Presented at the DIA EDC Conference,

Four Pillars for Clinical Data Management and Information Technology Architectures in the New Millennium

Presentation illustrating how some of the predominant themes of the digital marketplace will influence the design of the next generation information technologies for clinical research. Describes "four pillars" that must be a foundation for future CDM and IT architectures.

Accelerating Drug Approvals with Data Standardization

Presentation presented on behalf of the Clinical Drug Interchange Standards Committee (CDISC). Discusses a proposed model for defining metadata standards for FDA regulatory submissions.

The Elegant Machine

A new model for conducting clinical research programs in the future is beginning to evolve which will emphasize collaboration, interdependency, and close interactive sharing of information among the various stakeholders in the research process. The model will minimize redundancies, transcriptions, and data conversions in a continuous data flow, simplifying the data clarification process, and using the "best fit" technology tool for capturing and accessing clinical information. A generic data repository based upon evolving ICH/FDA data standards and the current state of alternative data capture technologies are reviewed.