Using Standards Experts to Empower End-to-End Data Flow

This discussion will highlight why study teams aspire to implement end-to-end standards but encounter development challenges. Standards experts possess comprehensive knowledge of end-to-end standards and can facilitate their implementation.

Register Free: https://www.appliedclinicaltrialsonline.com/act/data-flow

Event overview

Companies are looking to create a data flow process to reduce the time between last patient, last visit, and submission. Standards, specifically CDISC and FDA Guidelines, provide a foundation to operating a data flow process. Combined with central data storage system, time to delivery can be reduced to days.

The use of standards is not new, but holding to a single set of standards can be a challenge. Study teams are faced with new study designs and efficacy analytics. Providing an expert to guide teams in following standards, thereby empowering data flow, is a way to help study teams adjust to changes.

Three key take-aways

• How standards fit into data flow
• How a standards expert supports data flow
• Observed benefits of E2E expertise

Speaker:

Paul Slagle
Senior Director, Global Data Standards
IQVIA

Paul Slagle is the Senior Director of Global Data Standards Management at IQVIA. He has led multiple teams in the implementation and use of CDISC and other standards over the last 10 years. Paul is also an active member of the CDISC Standards team, leading the development of the ADaM Oncology Examples and multiple CDISC Therapeutic Users Guidance documents. He has also contributed to the SDTM Standards development.

Before working and leading the development of standards teams, Paul led various Statistical Programming teams for CROs and built the Statistical Programming team at a remote site for one CRO. Paul has been working in the pharmaceutical industry for over 20 years and, prior to that, worked in the R&D department for food manufacturing for almost 20 years. Paul is a member of the PharmaSUG Executive Committee and is the 2023 Chair for the PharmaSUG Annual Conference in San Francisco.

Register Free: https://www.appliedclinicaltrialsonline.com/act/data-flow