Webinar: Innovation in Data Management in an Era of Molecular Diagnostics and Genomic Testing

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In-vitro diagnostics (IVD) studies are rarely easy - and without the right technology resources, they can feel impossible. Pre-market clearance or approval of an IVD requires the demonstration of both analytical and clinical validity. The methods of data capture vary from paper to spreadsheets to databases, and the requirements for data handling are less defined than they are in drug trials. Precision has leveraged the Medrio eClinical system to deliver innovative solutions for analytical validation studies, focused mostly on the capture and handling of instrument data, as well as for clinical validation studies.

Attendees of this webinar will learn how the combination of a cost-effective, validated technology such as Medrio and data management SMEs who focus on diagnostics provides an efficient, right-sized solution for diagnostic companies. Join the webinar to learn how to:
  • Structure forms to include both operator-entered data and bulk-uploaded instrument data
  • Utilize forms to capture repeated runs and protocol deviations
  • Leverage edit checks to identify errors or missing data
Presented by
Courtnay Buonomo
Manager, Database Management
Precision for Medicine Oncology and Rare Disease

Courtnay Buonomo is the Manager, Database Management for Precision for Medicine Oncology and Rare Disease. She has over 20 years’ experience in the industry spanning Data Management, Database Development, Project Management and Clinical Support working for Sponsors, CROs and EDC Vendors. Her expertise lies in understanding the needs of a study and guiding sponsors on how to efficiently and effectively capture the necessary data taking into account the study objectives and the end user experience for site, clinical operations and clinical programming to ensure all users have the most organized data possible.

Charles Gemora
Senior Solutions Engineer, Medrio

Charles brings years of experience as an expert in eClinical software solutions to our webinar. He has worked closely with data managers and other professionals across the clinical research industry, from pharma to device and beyond, and has gained an insider perspective on the development of ePRO technology. He holds a Bachelor of Science from University of California, Berkeley, and is currently based in Atlanta, GA.

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