How Unified Insight Into Live Data Dramatically Reduced Trial Cost, Timelines, and Effort

November 4, 2020
Prevail InfoWorks

Webcast

***Live: Thursday, November 12, 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 Nov. 12, 2021***

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

Clinical trials are producing ever-growing volumes of data, at greater velocity and from more sources. As a result, development teams are struggling to foresee and avoid study problems – much less to effectively visualize and use data to improve study efficiency, data integrity, and outcomes.

Innovative new approaches, however, are giving biopharmaceutical organizations the tools they need to overcome these challenges and increase study success. In this webcast, we will examine one example: a North American pharmaceutical company, focused on autoimmune disease. The company had a promising therapy in a challenging therapeutic indication – one which had already seen more than 30 drugs tried by other sponsors. None of those 30 had succeeded.

A key factor in this company’s success, where so many others had failed? By giving researchers the ability to directly review – and immediately act on – unified, early observations across clinical and operational data, the company was able to:

  • Quickly deliver consistent, high-quality data to the FDA, resulting in the program being accepted for Fast Track designation and its Phase II study accepted as a pivotal study –saving $50 million in development costs and further reducing project timelines by eliminating the need for a second Phase 3 study
  • Conduct a successful rolling NDA submission with the FDA through auto-generated patient profiles/narratives, saving weeks of time and effort by easily populating patient narratives
  • Satisfy stringent requirements for detailed and frequent reporting to a DSMB to get timely permission to dose-escalate, while automating much of the effort – freeing expert researchers up from time-consuming administrative effort

And by putting this aggregated data directly into the hands of researchers, together with dynamic visualization and reporting tools, the company obtained an unlooked-for benefit. The R&D team discovered a promising new indication for the drug in the study data – and that new indication has already progressed to a Phase II trial.

Key Learning Objectives:

  • Discover how innovative software tools are helping trial sponsors increase study success through timely, data-driven insights into live studies, regardless of protocol, data, and system complexity – and without increasing alpha-spend
  • Examine and dispel the myth that it is too difficult, costly, and manually intensive to achieve a single, unified view across a study or program from all clinical and operational data sources including EDC, CTMS, labs, imaging, ECG, safety, IRT, ePRO and more
  • Explore the transformational improvements in development speed and quality gained by putting unified analytics and visualization tools into the hands of clinical researchers, letting them adjust data parameters on the fly and see the results immediately

Speaker: Patrick Keenan, Chief Strategist, Prevail InfoWorks

Time and Date: Thursday, November 12, 2020 at 2pm EST| 1pm CST| 11am PST

On demand until Nov. 12 2021.

Sponsor: Prevail InfoWorks

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

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