Validation concerns can hold companies back from adopting innovations in their clinical systems
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
- What validation needs to be done?
- Managing release cycles
- Best practices – ensuring you have a record of what you have and have not done, understand what you have so it is straightforward to reference
- Clinical Data Manager
- Clinical Data Director
- Head of Clinical Data
- Clinical Operations Manager
- Clinical Operations Director
- Data management
- Data science
- Clinical science
- Data standards
- Quantitative sciences
- Data monitoring
- Clinical leads
- Study managers
- Clinical study
- Data manager
- Clinical operations
Tanya du Plessis
Vice President of data strategies and solutions, Bioforum
Tanya is Vice President of data strategies and solutions at Bioforum. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data. A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).
Senior Solution Consultant, Vault CDMS
As Senior Solution Consultant for Vault CDMS Natalie is responsible for understanding customer challenges and objectives and providing technical product demonstrations tailored to address these needs.
Natalie has 16+ years industry experience in designing, implementing and supporting eClinical solutions to address the myriad of challenges faced across biopharmaceutical organizations. Her experience with clinical trials spans a broad range of sponsors and therapeutic areas across all phases and regions, allowing her to appreciate the differing technology considerations and needs.