Partnering with Central Labs, ECG and Imaging Core Labs
Venue: Hyatt Regency Islandia
|Event Date/Time: Jan 26, 2004||End Date/Time: Jan 28, 2004|
Welcome to the Partnering with Central Labs, ECG, and Imaging Labs Conference
We invite you to join the US gathering specifically designed for sponsors, central labs, ECG, and imaging labs to address relationship and standardization challenges through problem solving and best practice generation. The mission of the 2004 event is to position pharmaceutical companies for successful, efficient and safe new drug development on a global scale through series of comprehensive sessions, panel discussions and focused tracks.
The Partnering with Central Labs, ECG and Imaging Labs conference provides case studies focused on building successful relationships, data standardization, and expanding lab services. Co-presentations address current partnership challenges and strategies for resolving standardization issues that delay and complicate jointly led efforts.
THe program begins with a full day workshop on Creating Standards for Consistent Data Collection and Transfer Exchange led by Tom Grundstrum of LABCORP and Susan T. Steen of BRISTOL-MYERS SQUIBB. Workshop leaders ensure that you are well versed on enhancing data exchange and standardization in an increasingly global environment. An alternate morning workshop, Building Successful Lab/Sponsor Relationship Standards led by Dennis LaCroix of GENZYME and John Penman of CRL.MEDINET addresses the important issues and guides thought for specific processes to create successful laboratory / sponsor relationships. An afternoon workshop, led by RADPHARM, COVANCE, BIOIMAGING and MEDIFACTS explores how to ensure compliance with both ECG and imaging labs regulatory expectations for the ECG and Imaging Labs workshop.
The main conference kicks off by focusing on relationships between small pharmaceutical companies and small central labs to highlight the budget, contracting and data process. The conference continues with a detailed discussion focusing on building successful business relationships in the process to qualify and select a central laboratory led by Diane Stinson, Senior Contract Coordinator, MERCK & COMPANY. Once the selection process is complete, it is time to conduct a central lab regulatory and data assessment with Dwayne Brazelton, Senior Regulatory Affairs Associate, PFIZER, INC. In addition, hear from central lab experts as they present case studies focused on data standardization that explore:
Strategic approaches to implementing a successful clinical project team
Possibilities for integrated and validated laboratory data and eCRF integration
Using CDISC data standardization for clinical data
Viewing real-time lab data via electronic data capture systems
The conference rounds out on the final day with an expanded global focus on logistics challenges at the central lab. In addition, the morning sessions take an in-depth look at the specific relational intricacies for sponsors and ECG Labs, specifically QT elongation and changing FDA regulations. The imaging lab "boot camp" session uncovers the regulatory and internal lab processes. The afternoon separates the group for more detailed discussions of data standardization, and business relationships. The Data Standardization Track focuses on identifying a QA checklist for clinical data and a panel discussion with our data experts to overcome specific scientific data questions. Join the Round Table Session to address detailed data exchange challenges with central, ECG, imaging, and core labs. The Business Relationship Track details global logistics challenges and project management best practices. Join the Round Table Session that addresses contracting checklist challenges with central, ECG, imaging, and core labs.
We have expanded the 2004 event to incorporate ECG and imaging labs into the discussions with pharmaceutical company sponsors and central diagnostic labs. Benefit from our speakers’ first hand knowledge through interactive sessions that bring you the most innovative project and data communication solutions to create a highly efficient clinical trial process. Discover practical methods that produce successful partnerships, utilize skillful contract negotiation tactics, and manage the sensitive and critical data that is a pivotal link to proving the safety and efficacy of a new drug.