Data Standards for eCOA in Clinical Trials

Clinical Trials, Life Sciences,
  • Thursday, October 03, 2019

Adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. The US Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) have clearly embraced data standards for the submission of data, laying the groundwork for expanded industry adoption.  Collecting data in a standardized way is the next step to reduce messy, time-wasting efforts that can negatively impact patient safety, development timelines and resource utilization.

The adoption of data standards for electronic Clinical Outcomes Assessments (eCOA), the fastest growing technology in the eClinical space is critical to ensure quality and efficiency in this rapidly evolving discipline. This webinar will focus on Clinical Data Interchange Standards Consortium (CDISC) standards across data collection, tabulation, analysis and submission. Terek Peterson, the featured presenter, will discuss the benefits of implementing standards and which forms of data collection standards companies are requesting. He will also explore work in development, technology selection and the uncommon roles needed for a standardized eCOA deployment.

Speaker

Terek Peterson, Vice President, Clinical Analytics and Data Strategies, YPrime

Terek Peterson leads YPrime’s consultation efforts to help customers implement strategies around the development, use and commitment to data standards in their clinical research programs. Terek brings his nearly 25 years of clinical research experience at biopharmaceutical companies and contract research organizations (CROs) leading clinical analytic and standards teams. He has contributed to the advancement of industry standards across study design, data collection, tabulation, analysis and regulatory submissions.

Throughout his career, he served as a member of key advisory boards, working alongside FDA, PMDA and industry leaders, with non-profit organizations such as CDISC and Pharmaceutical Users Software Exchange (PhUSE). He is an industry-recognized expert on data standards and statistical programming-related topics.

Prior to joining YPrime, Terek was Senior Director of Global Statistical Standards at Covance where he provided leadership and direction for the company’s global standards strategies function, with a focus on CDISC. Before Covance, Terek served in a similar role at PRA International, where he provided leadership and direction for the company’s global standards strategies function and oversaw the company’s global clinical statistical programming function.

In his earlier career, Terek held positions of increasing responsibility involving statistical programming, technology implementation and process improvement. He has worked extensively with SAS technology deployments, supporting global clinical trials and submission activities.

Terek earned a Master’s degree in Business Administration from Rutgers University and received two Bachelor of Science degrees from the University of South Carolina.

Message Presenter

Who Should Attend?

This webinar will appeal to individuals with the following or related job titles:
  • Data Standards Professionals
  • Clinical and Statistical Programmers
  • Data Scientists
  • Data Managers
  • Clinical Project Managers
  • Clinicians
  • Investigators

Working in the following departments:

  • Biostatistics
  • Programming
  • Biometrics
  • Data Management
  • Data Standards
  • Data Governance
  • Procurement
  • Program Management
  • Project Management

What You Will Learn

  • Standardized eCOA deployment
  • Shifting industry attitudes and patient preferences
  • Growing scientific acceptability
  • Equivalence study conclusions
  • The importance of graphical control elements
  • Deployment considerations
  • Risk mitigation considerations

 

 

 

 

Xtalks Partner

YPrime

YPrime offers more than a decade of focused work with eClinical systems to expedite and improve the quality of patient management, clinical supplies, drug accountability and clinical data. Cloud-based interactive response technology (IRT) and electronic clinical outcome assessment (eCOA) platforms offer sponsors greater speed, precision and integration in clinical trial management.

Our data services and tools help sponsors bring together fragmented clinical research data into contextual information they can act on. YPrime’s technology and service offerings enable sponsors to move faster and more efficiently to their next development milestone.

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