Validation concerns can hold companies back from adopting the latest innovations in their EDC systems. Differing opinions on the appropriate level of system validation can also add stress within an organization. It is possible to implement new features and stay validated with relatively little effort if you use validation techniques tailored to cloud-based systems.
In this session, we address how to set the right approach, what to expect from a cloud EDC software provider and what you should expect to do as a sponsor or CRO to perform the initial validation and maintain a validated state following subsequent releases.
Participants will leave with strategies in-hand to conduct more efficient validation cycles and a greater ability to incorporate new system capabilities as they are released.
Key Learning Objectives
- Strategies to conduct more efficient validation cycles and a greater ability to incorporate new system capabilities as they are released
- How does a sponsor or CRO perform initial validation and maintain a validated state?
- The right Validation approach, what to expect from a cloud EDC software provider
Audience
- Clinical Data Manager
- Clinical Data Director
- Head of Clinical Data
- Clinical Operations Manager
- Clinical Operations Director
- Data management
- Biostatistics
- Data science
- Clinical science
- EDC
- Biometrics
- eClinical
- Data standards
- Quantitative sciences
- Informatics
- Data monitoring
- Clinical leads
- Study managers
- Clinical study
- Data manager
- CRA
- CDISC
- Clinical operations
