PHUSE2025·Connect·Drug DevelopmentConsiderations for the Submission of RWD Using CDISC, with Insights from HL7 FHIR and OMOP RE02 US · OrlandoSee metadata
PHUSE2025·Connect·Drug DevelopmentUsing the USDM and Ensuring Governance and Traceability to Unlock the Potential of Real-World Data Sources for Regulatory Submissions RE03 US · OrlandoSee metadata
PHUSE2025·Connect·Drug DevelopmentA Customised Algorithm to Evaluate the Quality and Reliability of Real-World Lab Data RE04 US · OrlandoSee metadata
PHUSE2025·Connect·Drug DevelopmentReal-World Data – Analysis-Ready Datasets: A Standardised, Specialised and Innovative Data Solution for Efficient Real-World Data Analysis RE05 US · OrlandoSee metadata
PHUSE2025·Connect·Drug DevelopmentApplications of Machine Learning and Artificial Intelligence in Real-World Data in Personalised Medicine for Non-Small Cell Lung Cancer Patients RE06 US · OrlandoSee metadata
PHUSE2025·Connect·Drug DevelopmentVerifiable Compute to Trust AI in Regulated Workflows RE07 US · OrlandoSee metadata
PHUSE2025·Connect·Drug DevelopmentWearable Technology: Enhancing Patient Monitoring and Real-World Evidence RE08 US · OrlandoSee metadata
PHUSE2025·Connect·Drug DevelopmentFrom Roadblocks to Roadmaps: Overcoming Challenges in Registry Data Reporting RE09 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsCDISC 360i: Implementing the CDISC Vision and Roadmap to Connect Standards from Design to Analysis Driving End-to-End Automation DS01 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsThe Development of the CDISC eTFL Portal To Support the Adoption and Implementation of the Analysis Result Standard DS02 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsCDISC Open Rules: A Deep Dive into Custom Rule Creation DS03 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsBiomedical Concepts: What Are They and Why Should I Care? DS04 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsEnable and Automate: A Technical Roadmap Defining CDISC’s Path to End-to-End Automation DS05 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsNavigating the Complexities of AESI: A Centralised Approach to Molecule-Level Management DS06 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsCompeting on Products, Collaborating on Standards: An Approach to Harmonising Vaccine Regulatory Submissions DS07 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsEnd-to-End Therapeutic Area Data Standards Development and Governance – A Case Study Involving CRS and ICANS DS08 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsSelecting GeARS: Analysis Results Standard Implementation Options for Accelerated Analysis and TFL Automation DS09 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsYour SCE is Only as Good as Your Data: The Central Role of Information Governance in Clinical Research DS10 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsEvolution of Genomic Data Mapping from PF to GF in SDTM v3.4: Concepts, Challenges and Controlled Terminology with Genetic Variation Examples DS11 US · OrlandoSee metadata
PHUSE2025·Connect·Industry StandardsChallenges of Genomic Data in Clinical Trials DS12 US · OrlandoSee metadata