Event Date/Time: Oct 27, 2003 End Date/Time: Oct 28, 2003
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Description

Case Report Forms: Best Practices for Design and Data Capture, is a program that will lead your clinical research team through the latest techniques in case report form design and offer a look toward future requirements for e-sub compliance. This hands-on seminar allows delegates to interact with our experts so they come away with a working knowledge of the latest technology, and learn the best ways to modify paperbased systems to ease the transition into electronic data capture and e-submissions.
Meet Our Advisory Board:

Jerald Schindler, Assistant Vice President, Biostatistics & Clinical Information Systems, Wyeth

Paula Fillow, Manager, Case Report Form Development, Purdue Pharma, LP

Mark Anderson, Sr. Director of Global Design and Reporting, Merck Research Laboratories

Gary Drucker, Deputy Director, Remote Data Operations, Bayer

Susan K. Howard, Therapeutic Area Manager, GlaxoSmithKline

Pasquale Calaiaro, Clinical Project Manager, Johnson & Johnson


Featured Joint Case Study by
Johnson & Johnson and Imperial Graphics

IIR is pleased to highlight a joint case study led by Pasquale Calaiaro, Clinical Project Director, Johnson & Johnson.

Pat’s responsibilities include overseeing the case report form design involved in four major studies in clinical trials in 18 countries worldwide. Included in those studies: Cisapride, a prokinetic drug from Janssen Pharmaceuticals, a division of Johnson & Johnson. Pat will lead a case study session revealing the thought processes involved in the most recent Cisapride data collection tool, from conception to printing and distribution.

Imperial Graphics worked with J & J to refine the Cisapride CRF. Keith Logsdon takes us through the best ways of communicating with the printer to tailor the CRF to the task at hand. Learn the unique approaches involved in this case study



In this seminar, delegates will also learn how to design more efficient CRFs that will ensure that their companies are collecting the most appropriate data for their protocols, standardization and system integration, how to work in a global environment, discuss metrics, and hear about the collaborative effort of CRF production between the printing vendor and the pharmaceutical company.
This two-day seminar prepares CRF designers, data base analysts and directors, systems managers, project coordinators and all involved in the collection of clinical trial data with the information needed to comply with the growing demands for electronic compatibility. Moreover, it will equip the Case Report Form Designer with new strategies for making the data collection process more streamlined and efficient.

At this event:

Participate in a Hands-on Workshop about Electronic Data Capture
Interact with Instructors in our Coaches Corner Designed to Let You Address Your Own CRF Issues
Understand the FDA’s JMP Software Program and Expectations for Compatibility
Find Out How Some Companies are Designing CRFs and Protocols Simultaneously
Listen to the Latest Ideas about Communication with CRF Printer and Distributors
Hear from Purdue's CRF Manager About How the Company Overhauled its CRF Operations
Problem Solve with Our Panel of Experts Examining Case Studies
Streamline Clinical Trial Procedures Using CDISC Standards in Paper-based and EDC Trails
With an expert speaker faculty comprising top clinical data experts from leading organizations such as: Johnson & Johnson, Wyeth, Merck Research Laboratories, GlaxoSmithKline, Aderis Pharmacueticals, and Bayer, Case Report Forms, 2003 is designed to meet your crucial CRF design and data collection needs.

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