Webinar:

Best Practices for Implementing and Maintaining Successful Standards

Sponsored by: Veeva

Focused on:

  • Clinical Trial Standards

Date: 19 January

148

Time: 1:30PM London/2:30PM CET

Best Practices for Implementing and Maintaining Successful Standards

Working with standards produces numerous benefits yet few organizations maintain them successfully over time. Regardless of what type of standards you develop within your organization, from operational and process-oriented to system integrations and clinical data standards, the same best practices can be applied to ensure success. This success is not determined by the size of the organization, but rather the ability to create, implement and most importantly, uphold them.

This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.

· Understand what to standardize
· Learn several approaches to standards development and when they make sense
· Ensure alignment with key stakeholders
· Maintain and govern standards over time
· Reduce overall configuration time

Presented by

Carla Reis,

Director, Client Services, 4G Clinical

Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.

Paul MacDonald,

Senior Director, Strategy Vault CDMS, Veeva Systems

Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.

Key Learning Objectives

  • Learn several approaches to standards development and when they make sense
  • Ensure alignment with key stakeholder
  • Maintain and govern standards over time
  • Reduce overall configuration time

Audience

  • Clinical Data (manager/director/head of) Clinical ops
  • Data management
  • Biostatistics
  • Data science
  • Clinical science
  • EDC
  • Biometrics
  • eClinical
  • Data standards
  • Quantitative sciences
  • Informatics
  • Data monitoring
  • Clinical leads
  • Study managers
  • Clinical study
  • Data manager
  • CRA
  • CDISC