Medical Review, Safety Signal Detection, Faster Submission

Medical monitors are overwhelmed by the sheer volume and variety of data they need to sort through to find, investigate, and react to safety signals. To reduce the risk of missing a safety issue and protect trial subjects, monitors need a way to quickly and easily find what they need, without having to hunt through irrelevant data. PerkinElmer Signals Medical Review is purpose-built for medical monitors, enabling them to detect safety signals faster and easier. With the innovative combination of targeted workflow and industry-leading analytics, Signals Medical Review reduces the overall time to submission without compromising safety.

Webinar Highlights
This webinar will enable you to:
  • Describe key challenges facing medical monitors in identifying and investigating safety signals
  • Identify the core capabilities to reduce the risk of missing a safety signal to protect the safety of human trial participants
  • Assess the importance of guided analytics in simplifying the work of medical monitors in reviewing in-stream safety data

Evaluate the impact of streamlined medical review on review cycle time and speed to market approval submission.
About the Speakers
Masha Hoffey
Director of Clinical Analytics, PerkinElmer Informatics

Masha Hoffey is the Director of Clinical Analytics at PerkinElmer. She has over eight years of experience with clinical and regulatory applications. She oversees the Clinical Practice, including product development and services. She also served as Head of Services and Support at Virtify, Inc. and was part of the business analysis teams at Merge Healthcare and PAREXEL International, driving clinical and regulatory metrics/reporting strategy and leading customer implementations. Ms. Hoffey holds a BA from Williams College and an MS in Regulatory Affairs for Drugs, Devices, and Biologics from Northeastern University.

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Don Sullivan Don Sullivan
PhD, Principal Solutions Consultant, PerkinElmer Informatics

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On-Demand Webinar