Does the Quality of Your Clinical Data Keep You Up at Night?
Medical device studies are complex and unique, with evolving regulatory oversight and compliance requirements. Mid-study changes are frequent and common. The ability to perform mid-study protocol changes and amendments without study disruption and migration, and have the ability to contain costs within sponsor requirements is critical.
When it comes to clinical trials, researchers and outsourcers have the same goals – speed, efficiency and flexibility – but how can you impact these variables today, for the specific needs of medical device studies? Adaptive design and site-centricity hold the key. This session will focus on a case study of a medical device trial, and will discuss the insights and outcomes of the trial based upon real-time results shared with CRO and the sponsor client as the study was being conducted. This case study allowed all parties to be aware of study progress with the flow of information on key research points and scores for medical device key indicators, resulting in 100% compliance with the evaluator training requirements in the study and subsequently a 100% error free assessment rate.
Dr. MaryAnne Rizk, Global Vice President, CRO & Biopharma Business Partnerships & Alliances, Oracle Health Sciences
Dr. MaryAnne Rizk globally leads the CRO Business Partnership strategy at Oracle Health Sciences. Prior to joining Oracle, MaryAnne was the Senior Director at Medidata’s CRO Partner program, leading the eClinical SaaS business through accredited CROs Channel partners. At Merck, MaryAnne had led both global clinical and commercial technology initiatives, including the collaborative Merck & Schering Plough joint venture and the deployment of Merck’s global clinical trial portal for principal investigators, and managed clinical outsourcing activities to key stakeholders of CROs, SIs and technology vendors.
Dr. Rizk received her Bachelor of Engineering and Masters in Management from Stevens Institute of Technology. She holds a PhD in Technology Management specializing her dissertation in Pharmaceutical Strategic Partnerships. Dr. Rizk is an active leader and speaker of Healthcare Innovation through chairing various board memberships and is a proud member of the following networks: Healthcare Businesswoman’s Association (HBA), New York Health Business Leaders (NYHBL), and the Drug Information Association (DIA).
Global Health Science Alliance Strategist innovating Clinical Organizations on cloud-based technologies and leveraging Big Data analytics to build strategic outsourcing partnerships in Pharma and Medical Device to improve Patient Health-Outcomes.
Srinivas Karri, Senior Director of Strategy, Oracle Health Sciences
Srinivas Karri is a Senior Director of Strategy at the Oracle Health Sciences Global Business Unit. He is responsible for clinical platforms and applications used by clinical trial sponsors to collect, manage and use clinical data as part of the clinical drug development process. Prior to working at Oracle, he was responsible for clinical applications at F. Hoffman La Roche managing and operating a variety of validated applications used by global clinical operations. He has over 17 years experience in the field of validation systems, clinical applications and pharmaceutical drug development and manufacturing in a variety of global roles. He has a degree in Chemical Engineering and a MSc in Process Systems Engineering from Imperial College, London.
David Shuford, Senior Solutions Consultant, Oracle Health Sciences
David Shuford, a Senior Solutions Consultant, has been with the Oracle HSGBU since the acquisition of PhaseForward in 2010. He supports HSGBU North American Sales of the eClinical suite of products with a focus on Electronic Data Capture, Interactive Response Technology, Siebel Clinical Trial Management System, Clinical Data Analytics, and Risk-based Monitoring solutions.
Brian Kelly, Vice President, Business Development, AG Mednet
Brian A. Kelly joined AG Mednet in 2010 after spending the last 8 years working in the field of imaging clinical trials. Mr. Kelly was most recently the VP of Marketing and Sales for SYNARC, the world’s largest imaging core laboratory. Prior to that, he served in the same role at Optasia Medical, Inc., a medical device software company producing image analysis tools for clinical trials. He also has experience as a project manager supporting global, clinical imaging trials in core laboratory settings. Earlier in his career, Mr. Kelly held roles in outsourcing and technical project management for Genuity, a tier one internet backbone provider, and as a warranted Contracting Officer for the Naval Undersea Warfare Center. Mr. Kelly has an MBA and a Bachelor of Science in Business Administration from Bryant University in Smithfield, Rhode Island.
Who Should Attend?
- Medical Device Manufacturers
- Contract Research Organizations (CROs)
What You Will Learn
- How to develop a quality transparency and flexibility plan to share key KPIs with all stakeholders: Learn how to address the impact of data harmonization, data unification, data transparency and data traceability
- How to leverage expert oversight and management in critical areas to avoid hidden costs in conducting clinical trials: Accurate, reliable insights by innovative Cloud-based technology supports the heart of the CRO and sponsor relationship, and impacts the development timeline and reformulations
- Considering challenges with executing a compliant medical device trial to develop a study design. How to develop a medical device trial’s study design for compliant ISO, FDA and EU regulatory reforms
AG Mednet is the world’s largest HIPAA and 21 CFR Part 11 compliant diagnostic imaging exchange network.