Case Study: How a CRO Wins with Direct Data Capture

With the rise of globalization, developments in technology and a changing regulatory landscape, the clinical trial industry is undergoing rapid and profound changes. The cost of bringing a novel drug or device to market is becoming more costly, complicated and time-consuming, yet at the same time, there is increasing pressure on the industry to deliver higher-quality and more cost-effective medical products more rapidly.

How can research organizations thrive amid unprecedented industry-wide change and pressure? While the answers are complex, new technology holds many of the keys. Over the past 20 years, technological breakthroughs have shaken up industries, from transportation to banking to business, accelerating the pace of innovation and opening doors to possibilities that were unheard of just a few years earlier. Clinical trials are one of the few remaining industries that have yet to leverage recent technological developments fully. In many ways, this makes sense: when lives are at stake, adopting new methodologies requires special care. 

However, with growing regulatory and industry support, clinical trial professionals are now on the cusp of a technological revolution that brings the promise of leaps in productivity and vast reductions in costs and timelines. One major player in the technological metamorphosis of clinical trials is eSource, specifically direct data capture. With the (European Medicines Agency) EMA’s recent qualification opinion citing its merits, it’s clear that the industry is going digital.

In this webinar, join Mike Novotny, Medrio CEO, along with Tanya du Plessis of data-focused contract research organization (CRO), Bioforum, as they share in-depth insight into direct data capture’s growing approval and real examples of its positive effect on clinical trial processes. Attendees will review the regulatory and industry initiatives that are pushing for the digital transformation and see eye-opening examples of direct data capture’s impact on clinical operations. Attendees will also get:

• An overview of the regulatory and industry support for eSource
• Key info on direct data capture’s benefits, including better data quality and reduced site burden
• First-hand examples of change management and direct data capture implementation
• How these benefits translate into significant reductions in trial costs and timelines

Speakers

Mike Novotny, Founder and CEO, Medrio

Mike Novotny applies 20 years of experience in research and software to his eClinical SaaS vision. Prior to founding Medrio in 2005, Mr. Novotny was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the United Nations and a manager of the fraud database at VISA. He holds a Bachelor of Arts from Stanford University and an MBA from Columbia University.

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Tanya du Plessis, Vice President, Data Strategies and Solutions, Bioforum

Tanya du Plessis has vast industry experience including over 14 years with IQVIA, formerly Quintiles and IMS Health, Inc. Leading various data management operation teams, Tanya has actively led strategies for customized data delivery solutions focusing on timely, high-quality data. She has driven numerous innovation teams and her dedication to optimal customer service delivery is visible through her long-standing relationships. Tanya is a certified clinical data manager (CCDM, SCDM) and holds a Master of Medical Science in Hematology and Cell Biology from University of the Free State, as well as project management professional certification (PMP, PMI).

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