Background:

A global top 5 pharmaceutical company was looking to evaluate an IDMP solution including core application functionalities, complexities involved in current data readiness, source systems and business processes for data collection and processing.

Objective:

The organization wanted to leverage the data in existing systems for IDMP compliance and maximize usage of the current functional systems through harmonized business processes.

Celegence was awarded a contract to help the customer with the business process related activities, including process definition & evaluation of the following activities:

  • Data Gathering
  • Submission Management
  • End-to-End Operational Data Management
  • Definition and evaluation of business strategy based on PoC findings
  • Validation & Compliance Analysis from business process perspective

While the technology vendor was responsible for the system implementation and integrations, Celegence managed and will continue to manage the IDMP data services for each iteration as they are defined going forward:

 

 

Key Achievements

 

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