Data standardization is the key to faster, more accurate analysis, resulting in successful submissions. By applying standards at the point of collection, you save time and reduce the risk of manual errors as you approach interim analyses, prepare regulatory documents, or simply make “no/no-go decisions” based on early results.
But if standardization is the key to efficient analysis and submission success, well-governed metadata is the key to achieving standardization. A central source of your organization’s metadata – able to effectively manage vendor data transfers, eCRFs, and submission datasets like SDTM and ADaM – ensures consistency across studies and standards, while also making the path from data source to deliverable completely traceable.
In this webinar, two standardization experts will outline the requirements a Clinical Metadata Repository (CMDR) must meet to cover the full range of data sources and programming needs. Learn what you should demand from your metadata management solution.
What you will learn:
- The business case for change – why modernize legacy systems/processes
- The benefits of adopting standardization
- What features you should expect from a Clinical Metadata Repository (CMDR)
- Key considerations for implementing a CMDR
- Strategies for a successful CMDR implementation
Who should attend?
This webinar will benefit those responsible for, or involved in, the implementation of a CMDR. It will also inform those looking to introduce standardization into their clinical trial process. This includes those working on data standards, data management, regulatory compliance, governance and biometrics in pharmaceutical, biotech, CRO and academic organizations, including:
- Clinical and Statistical Programmers
- VPs/Heads of Biometrics
- VPs/Heads of Data Standards
- VPs/Head of Data Management
講演者
- Erin Erginer, Senior Director of Product, Certara’s Pinnacle 21
- Kristin Kelly, Senior Principal CDISC Consultant, Certara’s Pinnacle 21
