Medidata Medidata

050720 EOS Webcast

[On-Demand Webinar]

End of Study Hacks: The New Digital Age

It’s no secret that the end of a study requires immense efforts by sponsors and CROs. One of the regulatory-required and resource-intensive end-of-study steps is sharing the end-of-study media back with the clinical research sites – a compliance process that has relied on dated and unsecure technology, such as CDs and DVDs, and manual efforts. Learn from industry experts how to eliminate compliance risks associated with the up to 65% of sites that lose, never receive, or acknowledge these CDs/DVDs, along with the site audits where findings arise due to data access. Improve site satisfaction and enhance process efficiency by simplifying and automating the exchange of study data with sites. Discover how Sponsors and CROs are challenging the status quo by developing new models to improve end of study compliance and productivity.

Key Learning Objectives:

  • Current challenges and practices for managing end of study media
  • Methods to mitigate security, inspection finding, regulatory risks
  • Innovative technologies and practices to challenge the status quo
  • Case studies resulting in increased site satisfaction due to new digital content delivery practices

Who Should Attend:

  • Sponsors
  • CROs
  • Clinical Ops: Program Manager, Project Manager, TA Lead
  • Data Managers: External Clinical Data, Clinical Data Management, Database Development, Database Validation,
  • Data Management Project Manager, Clinical System Design, Data Science
  • IT: Archive, Warehousing, Business Improvement, Innovation

Speakers

Perry Steinberg
VP Product
Medidata, a Dassault Systèmes company

Perry Steinberg is the General Manager and Product Leader for Edge eTMF and the Regulated Content Management Platform at Medidata Solutions. He has led the business and technology development for multiple products across the Medidata Clinical Cloud, including the Strategic Monitoring Suite and RTSM. He has over 20 years of experiencing leading artifact, document and data initiatives for Fortune 500 companies. Perry holds a BA in economics and computing from UCLA and an MBA in marketing and corporate strategy from University of Michigan, Ross School of Business.

Tim Akers
Solution Specialist
Medidata, a Dassault Systèmes company

Tim Akers is a Solution Specialist at Medidata, focusing in Clinical Trial Operations. His background surrounds various roles within the lifecycle of clinical research. He has vast experience as a monitor on multiple late stage trials primarily in Oncology. He also has experience as a Project manager in Early Clinical Development. During his time at a large CRO, he helped develop strategic Vendor Managementinitiatives focusing on controlling and improving how business is conducted with 3rd party vendors in an outsourced clinical trial. Tim has unique experience as he transitioned to a commercial role, focused on helping biotech and mid market customers graduate through IND enabling and into First in Human trials. During his time at Medidata, Tim has played a leadership role in the development of Medidata’svision for CTMS, eTMF, RBQM, and most recently Medidata’sEnd of Study Media Solution. Tim holds a BBA from Middle Tennessee State University, with a focus in operations and supply chain management.

Arzu Akturan
Sr. Solution Consultant
Medidata, a Dassault Systèmes company

As a Senior Solution Consultant, Arzu is responsible for presenting the capabilities of the Medidata Platform to the Enterprise Market. She has nearly 11 years of pharma, biotech and medical device industry experience, delivering complex system solutions in support of client needs to drive excellence in clinical trial execution. She has over 20 years of Sales Engineering experienceacross multiple industries and holds a BS in Computer Science and an MBA from Tennessee Technological University.