How Unified Insight Into Live Data Helped One Sponsor Succeed Where Many Others Failed
***Live: Monday, December 7, 2020 at 2pm EST | 1pm CST | 11am PST***Discover how a North American pharmaceutical company succeeded where dozens of trial sponsors had failed. Leveraging innovative new clinical software, the company helped transition its breakthrough science into trial success, by delivering consistently impeccable data that accelerated the program with far less cost and effort – ultimately leading to a successful submission***On demand available after final airing until Dec. 7, 2021***
- Accelerate clinical development and reduce patient and operational risk, including avoiding a clinical hold, by streamlining eligibility checking, medical monitoring, and DSMB/CEC communications with rapid access to high-quality data and detailed reporting
- Convincingly demonstrate the drug’s benefit-risk profile to the FDA, with the agency accepting a Phase 2 study as pivotal - saving $50 million in development costs and reducing timelines by several months
- Free key study personnel from heavy manual effort through automated data flows and reconciliations, for example conducting a successful rolling NDA submission through auto-generated patient profiles/narratives
- Explore the key challenges to easily and cost-effectively supporting risk mitigation strategies in studies with data integration and analytics, and how study teams are effectively overcoming these obstacles
- Review how trial sponsors are obtaining a far clearer understanding of what their drugs are doing in the indication while the study is underway, without increasing alpha-spend
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Related Articles
- The Impact of ICH E6(R3) on Biospecimen Management
June 25th 2025
- The Top 5 Myths About eCOAs In 2025
March 25th 2025