Winchester Business Systems continues its nationwide seminar series on the benefits of electronic clinical trial management at the IBM Innovation Center in Waltham, MA on Wednesday, May 13, 2009.
Discussed at the seminar will be areas of potential savings through a centralized, shared approach to trial management. This complimentary, full-day event, is invaluable to any life science professional involved with trial management.
IBM Innovation Center
404 Wyman Avenue
Waltham, MA
Despite the benefits and opportunities that electronic clinical trials can offer, many organizations are finding it difficult to predict and capitalize on the benefits that can be realized by utilizing technology to manage trials.
Your organization needs full participation by all departments – planning, operations and finance – to successfully manage Phase 2 and 3 trials on a global basis.
The current systems used by most organizations – individual spreadsheets and disconnected databases, cannot support the increased volume and complexity of these trials. In fact, they can significantly slow down the time to close-out and increase the risk of FDA rejection due to incomplete or non-compliant information.
Learn how a centralized, collaborative system can increase accuracy, reduce time and improve the overall clinical development process. In this seminar, you’ll get the latest perspectives on the following topics:
- How to effectively manage and retain good investigators by providing easy-to-use tools to manage trials and by accurate and timely payment.
- How to realize “Early Warning” signals of potential bottlenecks and barriers to trial progress.
- Creating an integrated and collaborative work environment for clinical trial management designed to help streamline and automate the operations of clinical trials and enable better and faster reporting.
- A review of changes to SOPs that can improve clinical operations when moving to an electronic environment.
- Areas of potential savings available through a centralized, collaborative approach to trial management.
Who Should Attend?
Clinical Project Managers, Vice Presidents and Directors of Clinical Operations, Financial Managers who are responsible for clinical budgets, CIOs and IT Managers who support clinical operations.
About Your Workshop Leaders
Michael O. Regentz, CSI, CPIM, Managing Director, Winchester Business Systems, possesses experience in the pharmaceutical and medical device industries architecting closed-loop systems for clinical trials and quality systems.
Robert S. Saldana, PharmD, MSc, is Principal Consultant of Stage One Biotech, LLC, a Boston-based consulting firm specializing in designing and executing complex early phase clinical trials for industry firms. Dr. Saldana is an accomplished clinical operations manager with extensive experience gained in planning and executing over 120 global trials in a broad range of therapeutic areas.
Tomasz H. Zastawny PhD, DSc, MSc, Managing Director, Executive Clinical Research Consulting. He is also the member of Supervisory Board for KCR S.A. that is a leading European R&D organization. Dr. Zastawny is a clinical research professional and scientist with more than 20 years of proven achievements in international clinical research, science and corporate business management.
Scott A. Wallace, East Region Healthcare and Life Sciences Sales Executive responsible to General Business IBM Healthcare and Life Science clients. Prior to IBM, Scott was VP of Business Development at BG Medicine in Waltham, MA. Scott has worked for industry leaders such as Abbott Diagnostics, IDEXX Laboratories, B. Braun Medical and MicroTouch Systems.
Rodney Sassaman, Technical Consultant, IBM Innovation Center
Downloads
CTMS seminar flyer Waltham IIC 2009
