In global research and development environment, sponsors and CROs are faced with day to day challenges to effectively design, collect, manage, report, and archive clinical data. In this complex research environment, multiple global research sponsor partners, technology vendors, and service providers work together to conduct clinical trials. Data standards serves as the common language amongst them and with the agencies.

Agenda:

• Scale, Scope and Variations of CDR implementations
• Functional touch points considerations
• Operational aspects of implementing a CDR and technology landscape
• Leveraging the contents of the CDR and implementing new and effective clinical processes
• Implementing a Governance model to preserve the quality of the contents
• Making the transformation from pre-standards era and still meeting the operational needs when making the transformation

Today, in the biopharmaceutical industry there is enthusiasm to adopt and transform, as they understand the benefits of clinical data and regulatory submission standards, panic and mixed feelings on ROI as they consider implementing some of them. There is also reluctance as they sort out the priorities on what standards to start with. The external factors to consider are, the agencies that the sponsor companies are planning to submit to, segment and focus of their company, knowledge of how their peers are adopting to standards, geographical presence, maturity of the standards and tools in the market space for that standards etc. The internal factors that they need to consider are, their general preferences and style of conducting clinical research, readiness to transform, availability of resources with enough internal knowledge and external knowledge who can fit them together and finally time the implementations. In addition to all these considerations while planning a great deal of attention needs to be given to sequencing the standards implementation and creating a roadmap for this transformation.