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.
Watch this webinar to learn how to:
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.