Discover the True ROI of eRegulatory in Clinical Trials

Precision medicine and immunotherapy clinical trials transform research while spiking demand at the research centers best equipped to conduct them efficiently and compliantly. In parallel to this increasing demand, study volume and protocol complexity are on the rise. These centers need to scale their operations and accelerate trials while remaining compliant. As a solution to these challenges, tools are emerging for the automation of study tasks, including Florence eBinders™, but how can a site manager prove that they provide a positive return on investment? This whitepaper examines six economic drivers paying back the cost of an eRegulatory and eSource platform (eBinders) so that centers can make an informed decision as they scale to advance cures. The findings show that oncology centers can capture nearly $20,000 of benefit per study. The clinical trial landscape is changing. Research, especially in oncology, is turning toward precision medicine and immunotherapies that more precisely target disease. While patient outcomes are improving (Five-year cancer survival rates increased from 49% in the 1970s to 68% in the 2010s (AACI 2017)), precision medicine harbors three unexpected consequences for research sites: 1. Study volume increases as disease areas become sub- segmented and paired with more precise therapies 2. Protocol complexity increases as therapies themselves become more complex 3. Enrollment requires greater precision resulting in fewer enrolled patients per site and requiring reduced overhead per patient Indeed, according to EP Vantage Analytics, in the past five years immuno-oncology protocols have become more complex and study volume has tripled (EP Vantage Analytics, 2017).

Study Abstract

Study Introduction

The ROI of an eRegulatory Platform

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