Clinakos CEO Inder Jaggi has been invited to present at CDISC’s 2021 US Interchange conference. The title of his talk is “Impact of HHS Final Data Blocking Rule on RWD/RWE Generation.” This talk describes the increasingly important role of RWD and RWE in biopharmaceutical research, drug approvals and label extensions. The FDA now has published frameworks for utilizing RWE to support drug approvals, new indications and post-approval studies.

The talk describes a potential method to link patient records across thousands of data sources through a common data model to yield high data accuracy and fidelity. Coverage includes generating Fit-For-Use Auditable data with longitudinal patient records integrated with PROs and Patient Surveys. It also includes approaches where the use of AI and Machine Learning can be leveraged for many current RWE use cases.