A few important considerations for organizations planning Clinical Trial Management System (CTMS, such as Oracle Siebel Clinical) implementations.

1. Oracle Siebel Clinical (CTMS)
Implementation Approach Considerations
• Single release or multiple releases?
– Consider a phased (multi-release) approach starting with a near-vanilla
product rather than delivering all desired functionality in a single release;
requirements tend to change after “real-life” use of the system
• Magnitude of organizational impact?
– Expect to invest in changes to business processes, changes to
organizational roles, and changes to SOPs as part of the implementation
project, though not necessarily in the first phase
• Technical scope of implementation?
– Understand the functional and technical adequacy of the CTMS-related
systems and infrastructure (EDC, IVR, finance, data warehousing,
reporting, etc.) currently in place within your organization
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