Data Management in Clinical Trials is based on the interaction between the delegates and the presenters on the following topics:
Current State of Standardization and Integration in Data Management
- Latest developments in data standards implementation
- Implementation of SDTM – New standards & old data: How to make the ends match?
Why, Where and How to Outsource Your Clinical Data Management Successfully? (Or Not to Outsource at all?)
- The need for Outsourcing – what kind of alternatives are out there?
- Three Industry experiences with CDM Outsourcing
New Clinical Data Management Processes and Technologies – What Are the Challenges and the Opportunities?
- Challenges associated with widespread EDC technology adoption
- Other eClinical systems and clinical trials technologies
- End-to-end solutions/ technology
- eCRF design and development
Quality Control Activities in Data Management
- Data Quality: How much is enough?
- Data Inspection, Auditing
- Requirements for GCP-compliant Data
- Management in multinational clinical trials (The experiences of ECRIN)
The Evolving Role of Clinical Data Managers
- Changing role of Clinical Data Managers
- Will the role of Clinical Data Managers survive and continue?
