Implementing CTMS/eTMF Clinical Vault as the Client Partner
Background Information & Key Problem
A Mid-tier Pharmaceutical company decided to add a Country Operations team to support the management of clinical study activities in-house. This effort was designed to address the complexities of eight different TMFs managed by vendors for the client.
The core challenge was implementing a new organization, processes and tools in six months to support the launch of the new platform for use on first studies.
Daelight’s Solution
The Daelight team supported clinical study operations by defining business processes that fit within the larger organizational process effort.
In parallel, Daelight Analysts engaged with Veeva and the client team to define workflows, fields and data collection structures that aligned with emerging processes.
Daelight Analysts led security structure definition and provided the context needed for final configuration decisions.
Created plans, specifications, configuration and testing documentation for validation.
Generated training documentation and provided stakeholder communication decks.