March 29-30, 2012 | Chicago, IL

ABOUT THE CONFERENCE

Throughout the pharmaceutical and biotechnology industry, executives are continually working to reduce the overall time to product launch; primarily through streamlining clinical research time. Unfortunately, clinical trial delay is also one of the most frequently cited reasons for product launch delay, which leaves many organizations working towards solutions aimed at reducing clinical delays. One strategy being utilized by forward thinking organizations is to streamline the earlier phases of clinical research in order to, in a way, “set up” for later stage trials, and regulatory requirements. Through shortening and more efficiently conducting the early phases of research, companies will ultimately find that their overall time to approval and market has been significantly reduced.

Through tighter control of clinical operations throughout the early phases of research, companies will find success in their overall studies. Executing efficient and cost effective studies in the early phases of research will enable companies to have a better understanding of the requirements for clinical studies in early of the first three phases of research that will ultimately support regulatory clearance and market acceptance.

As with all Q1 programs, the focus of this event will not only include case studies and panel discussions, but also opportunities for informal networking and knowledge share among the program participants. In a rapidly evolving marketplace such as this, making meaningful connections is a primary objective of many executives, and Q1 programs help to foster new and existing connections.

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TOPICS TO INCLUDE:

• Establishing a Strong and Efficient Study Design for Phase I-III
• Optimizing Early Phase Clinical Trials to Accelerate Proof of Concept and Transition into Late Stage Research
• Strategies for Successful Site Selection in PHASE I-III Trials
• Best Practices for Appropriate Site Management
• Developing and Sustaining Partnerships with Sponsor, Site and Clinical Investigators
• Cost-Saving Strategies for Accurately Budgeting Early Phase Research
• Analyzing Trends in the Emergence of Outsourcing CROs Outside of the US
• Comprehensive Approach to Ascertain Regulatory Compliance at International Clinical Sites
• Successfully Enrolling the Optimal Subjects into Phase I-III Studies
• Planning Ahead: Early Considerations for Patient Retention
• Defining Necessary Considerations for Recruiting and Retaining Special Populations
• Subject Recruitment for Early Phase Studies Outside of the US
• Setting Measures in Phase I-III Clinical Research to Maintain High Levels of Patient Safety
• Regulatory Considerations in Implementing Risk-Based Approaches to Document Monitoring
• Understanding the Implementation and Management of Phase I-III Data Collection

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KEY PRESENTERS TO INCLUDE:

Deborah M. Manzo, MScOL
Director, Clinical Development Operations
previously with Biogen Idec

Suzann Johnson
Therapeutic Area Liason, Cardiovascular & Metabolics, Global Enrollment Strategies
Janssen Research & Development, LLC, a Johnson & Johnson Company

Nicole Richie, PhD
Associate Director, Clinical Research Operations Strategy Lead
Pfizer Global Research & Development

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