New regulatory expectations are taking shape, including the need for interactive and transparent clinical data handling, increased safety data demands and electronic data (CDISC) submission. Trial sponsors must carefully plan their data consolidation and analysis strategies not only in preparation for CDISC-compliant submissions, but to respond to market influences and evolving clinical partnership models.

Replay the webinar with Cytel expert Angelo Tinazzi and Halloran's  Mark Vermette and gain: 

• Guidance on the practical steps to take when considering and implementing industry data standards
• Insights into the critical success factors for preparing a compliant submission; are you prepared for what the FDA expects?
• Understanding of how planning and implementing data standards can improve your overall clinical research oversight

While applicable to any sized biopharma developer, the insights will be especially valuable to biotech and specialty pharma sponsors early in their clinical research efforts.

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