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The client successfully adopted RIM transformation, resulting in greater efficiency and enhanced data quality.

The client is a Fortune 500 biopharmaceutical company that discovers, develops, and markets innovative medicines. Their products are known worldwide for the treatment of several serious diseases. 

Challenge

The client, a global bio-pharmaceutical company, needed to implement change management for a major regulatory information initiative, as well as a user adoption program.

Solution

Orion led change management for RIM deployment by first defining change management and the communication program, along with its associated initiatives. Next, the Orion team defined Change Management Liaison Roles and Responsibilities to support the global deployment of Veeva RIM. Key responsibilities included:

  • Being a champion of change and the key point of contact for end users
  • Encouraging the active use and adoption of RIM business processes and system
  • Proactively supporting the global deployment of RIM business processes and system capabilities
  • Ensuring data is of highest quality
  • Supporting/delivering clear, simple and comprehensive training on RIM processes
  • Being aware of cultural change issues and driving appropriate change in the organization
  • Overcoming constraints and challenges
  • Driving acceptance and commitment during deployment
  • Communicating and assisting in the establishment of a clear link between the organization’s goals for high data quality and users’ individual role in achieving these goals and objectives

Then, Orion defined the operating model for global user engagement, user adoption of new processes and systems, training, data quality assessments and hypercare. Our team members from North America and Asia Pacific were responsible for providing these services.

Impact

The client successfully adopted RIM transformation, resulting in greater efficiency and enhanced data quality.

healthcare & life sciences

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FAQs

Your questions,
answered.

Regulatory information management, or RIM, is the process of managing regulatory data, documents, submissions, approvals, and compliance information. It is commonly used in pharmaceutical and life sciences companies to support regulated product operations. 

Change management is important for RIM adoption because new systems and processes affect how teams work. Clear communication, training, and user support help employees understand the change and use the system correctly. 

User adoption supports regulatory transformation by ensuring employees actively use new processes and systems. Strong adoption improves data quality, process consistency, collaboration, and compliance across global regulatory teams. 

A change management liaison supports users during system deployment and process change. This role helps communicate updates, encourage adoption, deliver training, address challenges, and connect individual responsibilities to broader data quality goals. 

Data quality is important in regulatory operations because inaccurate or incomplete data can affect compliance, reporting, submissions, and decision-making. High-quality data helps pharmaceutical organizations manage regulatory information more reliably. 

Companies should plan user adoption programs before deploying major systems or process changes. Early planning helps prepare users, reduce resistance, improve training, and support smoother implementation across regions and business teams. 

Hypercare is the post-launch support period after a new system or process goes live. It helps users resolve issues quickly, stabilize operations, and build confidence during the early stages of adoption. 

RIM transformation can improve efficiency, data quality, user engagement, and regulatory process consistency. It helps life sciences companies manage regulatory information more effectively across global teams and regulated markets. 

Answer