Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena. Particularly 2016 will bring important changes in the European Regulatory framework once the ICH E6 Addendum kicks in. At that time ‘Quality’ is no longer the outcome of well-designed processes, but it should be an explicit and very well-considered strategy in the way we design our processes and studies. Risk-Based Monitoring will be codified in Good Clinical Practice, and many organizations will have to revisit their Standard Operations Procedures, processes and study-related documents. And obviously, this will have an impact on the roles of professionals working in clinical development.
In three parallel themes, changes and developments within Clinical Data, Clinical Operations and Statistics will be addressed. During a joint plenary session, topics that bind both groups will be discussed: Risk-based Monitoring, the status of eSource and independent 3rd parties, and Quality Management in Outsourcing.
- e-Solutions (eSource, e-Trial Master File, Cloud Solutions, e-Health)
- End-To-End Data Integrity: Data Quality and Data Integrity
- Inspections and E-Solutions: Case Studies on Regional Differences
- How Risk-Based Monitoring Binds all Stakeholders - Data Managers, Statisticians, Monitors, Investigators and Inspectors
- How the Patient Socialisation Affect Clinical Trials
- Managing Outsourced Studies: How to Prevent Fragmentation?
- Impact of Local Cultures and Working Environments on Global Pharma Processes
- Data Sharing and Clinical Statistics
- Exchange views and experiences with peers
- Discuss the future aspects of clinical research and need for tools and skills
- Bring together people working in different interfaces to shape and improve practices
In three parallel themes, changes and developments within Clinical Data, Clinical Operations and Statistics will be addressed. During a joint plenary session, topics that bind both groups will be discussed: Risk-based Monitoring, the status of eSource and independent 3rd parties, and Quality Management in Outsourcing.
Featured topics
- How to Incorporate Risk-Based Quality Management- e-Solutions (eSource, e-Trial Master File, Cloud Solutions, e-Health)
- End-To-End Data Integrity: Data Quality and Data Integrity
- Inspections and E-Solutions: Case Studies on Regional Differences
- How Risk-Based Monitoring Binds all Stakeholders - Data Managers, Statisticians, Monitors, Investigators and Inspectors
- How the Patient Socialisation Affect Clinical Trials
- Managing Outsourced Studies: How to Prevent Fragmentation?
- Impact of Local Cultures and Working Environments on Global Pharma Processes
- Data Sharing and Clinical Statistics
Learning objectives
- Prepare for the changes brought by Clinical Trial Regulations and ICH E6 Addendum- Exchange views and experiences with peers
- Discuss the future aspects of clinical research and need for tools and skills
- Bring together people working in different interfaces to shape and improve practices
