Prevail InfoWorks

https://www.appliedclinicaltrialsonline.com/act_w/unified_insight

 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

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

Patrick Keenan, Chief Strategist, Prevail InfoWorks

 Monday, December 7, 2020 at 2pm EST | 1pm CST | 11am PST

Webcasts

***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***

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

Articles

Discover how a small pharmaceutical company leveraged unified visualizations and reporting into study data to save $50M in study costs and months in development time.

Prevail InfoWorks

Articles

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

Case Study - Insight Reduces Trial Cost and Timelines

Case Study: Insight Reduces Trial Cost and Timelines