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.

Results

• Delivered on time and on budget.