How Unified Insight Into Live Data Helped One Sponsor Succeed Where Many Others Failed

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/unified_insight​

Event Overview: In this case study webinar, we explore how a North American pharmaceutical company’s innovative development program for an autoimmune disease treatment succeeded, when more than 30 drugs from other sponsors for the same indication had failed.

The key? Identifying specific medical, operational and logistical risks in the study, and then implementing analytic and workflow tools flexible enough to support tailored risk mitigation strategies – and robust enough to easily and cost-effectively aggregate ALL clinical and operational data from EDC, labs, safety systems, and more into a single unified view, regardless of data type or source. By giving researchers timely, direct access to high-value visualizations and early observations across every aspect of the study, with minimal effort through supporting workflows, the company was able to:

• 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

Key Learning Objectives:

• 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

Examine the reasons behind the myth that it is too difficult and costly to achieve a single, unified view across a study or program from all clinical and operational data sources

Speaker: Patrick Keenan, Chief Strategist, Prevail InfoWorks

Time and Date: Monday, December 7, 2020 at 2pm EST | 1pm CST | 11am PST

On demand until Dec. 7 2021.

Sponsor: Prevail InfoWorks

Register Free: ​https://www.appliedclinicaltrialsonline.com/act_w/unified_insight​