Join Medidata experts for a discussion on the challenges in device supply management and remote monitoring to realize quality while mitigating study and site risk during these challenging times. As COVID-19 continues to spread, the impact on clinical trials is unmistakable. Medidata has seen a disruption of clinical monitoring, patient visits, and supply chains, leading to substantial impact to the:

• Ability to ensure overall patient safety and trial integrity
• Management and reconciliation of device supply and tracking
• Ability to manage and review critical documents throughout the trial

Learn from our experts on how Rave RTSM and Rave Imaging Critical can help address these challenges and how extraordinary measures must be implemented and trial operations adjusted for both managing your device supply and acquiring and managing critical documents remotely.

Supply Management
As clinical trials evolve and industry challenges persist, so does the demand for medical device trials coupled with robust RTSM solutions. And like most traditional clinical studies, medical device trials are faced with complex risks and challenges such as strict compliance with regulatory requirements, burdensome efforts focused on manual workflows, and the need for faster insights. Medidata takes into consideration these challenges and industry approaches to solutions and developed technology that leverages a unified platform approach.

Remote Monitoring
Regulatory guidance allows for sponsors to find a way to securely perform critical document management and SDR remotely in certain regions of the world. Medidata has tailored its Rave Imaging
workflow tool to align with the current situation and enable clients to rapidly and remotely deploy a method to assist monitors in critical document acquisition, workflow, and Source Document Review (SDR). Rave Imaging Critical is a streamlined and quick-to-implement solution that helps fill the gap when studies have critical timelines and no secure option to collect, de-identify, manage, review and verify critical study documents.

Featured Speakers

Kevin Collier VP Product, RTSM Medidata

Kevin is Vice President of Product with global responsibility for product strategy and delivery of Medidata’s RTSM solution. Kevin has spent his entire 30 year career in the Life Sciences arena working in clinical research, medical devices, systems and software delivery, and project management. Kevin has a well-rounded background that is technology focused and includes a deep understanding of the Pharmaceutical industry and clinical trial life-cycle. Kevin first started in IRT/RTSM at ICON Clinical Research in 2002 where he led the Project Management team responsible for large clients and was instrumental in unique and innovative design initiatives.

Debbie Anderson Principal, Imaging Medidata

Debbie Anderson is Principal of Imaging, promoting education and supporting sales efforts with Medidata CRO partners. She has significant experience working across Sponsors, CROs, core labs, and sites to adopt medical image technologies to help automate image acquisition, distribution, assessment, and data collection. Prior to joining Medidata, she was in the CRO industry for 16 years including Imaging CROs and Central Labs and earned a BS in Biology.