Thursday - April 26, 2018 - 10:00

Achieving a streamlined IRT development process

IRT systems are critical to both randomisation and efficient drug supply management, but too often they are an afterthought for a study team juggling many conflicting priorities. With an efficient internal process, preferred IRT vendors and standardised IRT modules, processes and documentation, IRT development can be achieved in a streamlined fashion delivering an optimum IRT system with a fraction of the customary frustration and duplication of effort.

• Appreciating the importance of IRT
• An analysis of historical models
• Understanding the importance of preferred IRT providers
• Discussion around how best to achieve Standardisation

Thursday - April 26, 2018 - 16:20

Panel discussion: Global data sharing in the world of innovation. Benefits and Security Risks

• How Data sharing could advance scientific discovery and improve clinical care?
• What are the guiding Principles for Sharing Clinical Trial Data?
• Need to protect the privacy and honor the consent of clinical trial participants
• Sharing fosters sound regulatory decisions
• What are the key roles and responsibilities of stakeholders in the sharing of Clinical Trial Data?
• The Approaches to Mitigating the Risks of Data Sharing