...
End-to-End RBQM Webinar: Value-Driven Clinical Data Review, Together | ||
Clinical data review is no longer just a technical checkbox – it’s a strategic, cross-functional effort that can make or break the success of a clinical trial. When teams collaborate across functions, align on risk, and focus on value-driven review, the result is more reliable, coherent and compliant trial data. In this session, we’ll explore how to move beyond traditional data cleaning by embracing a collaborative, risk-based approach. Learn how functional interdependencies – when properly understood and leveraged – can drive smarter, more efficient reviews. We’ll also host a dynamic roundtable featuring voices from big pharma, tech and CROs, who will share real-world insights, challenges, and best practices for building effective, cross-functional data review strategies. Whether you’re in data management, clinical operations, biostatistics, or a supporting function, this session will offer actionable strategies to foster collaboration and value-driven data review processes. This webinar will be held virtually on 26 June at 10:00 (EDT)/ 15:00 (BST) / 16:00 (CEST)
|
...
The Implementation of Estimands (ICH E9 (R1)) using Data Standards project within the Optimizing the Use of Data Standards Working Group, have published a new White Paper and Example Document! This white paper provides recommendations and examples to illustrate the implementation of the estimands framework introduced by the ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials [ICH E9(R1), 2019] using data standards (as part of the clinical data flow). |
|---|
...
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
...