(Recorded on October 23, 2014)

Sponsored by 

Prevailing market forces in the biopharmaceutical industry—greater economic and regulatory pressures and the demand for improved safety and efficacy continue to grow. Improved utilization of data analytics promises to improve the effectiveness of research and development. However, organizations are struggling to manage the volume and diverse formats for pre-clinical study data spread across the organization.

In this webinar, David Lowis, D. Phil. of Certara, makes the case for adopting a solution that allows immediate access, visualization and analysis of pre-clinical data for optimized decision making, while leveraging the FDA mandated CDISC-SEND data standard. Joining Dr. Lowis will be Stuart Horowitz, PhD, President of Institutional Services at WIRB-Copernicus Group. Dr. Horowitz will frame this challenge of pre-clinical data access/analysis with an eye toward accelerated regulatory approval. Hear how a holistic approach can deliver business value and competitive advantage and provide rapid insights that let you anticipate and respond to regulatory questions and accelerate promising programs or stop unproductive ones more quickly so you can get your product to market faster.

Learning Objectives:

• Learn how real-time pre-clinical data analyses reduces delays in study adjustments and decision making
• Better understand the pharmacodynamics and toxicities of investigational drugs
• Understand how cross study data analysis reduces response times to the FDA and other regulatory bodies
• Learn how to simplify data analysis by mapping terms found in study datasets to a common standard.
• Understand why the CDISC SEND data format standard for data transfer is becoming increasingly important in pre-clinical studies (and not just for submission)

Speakers:

David Lowis, D. Phil, Senior Director, Product Management, Certara USA

Stuart Horowitz, PhD, President of Institutions and Institutional Services, WIRB-Copernicus Group  (WCG)