Pharming’s Three-Step Approach to Adopting a Unified RIM Platform

When transitioning to a new unified RIM solution, effective change management is key to maximizing platform value and driving continued adoption. Over the course of eight months, Pharming took a systematic approach to successfully implement and adopt Veeva Vault RIM to optimize its regulatory operating model.

Accelerating regulatory submissions

Pharming is a global biotech company that develops and commercializes innovative protein replacement therapies and precision medicines for underserved rare disease patients.

Pharming aimed to eliminate redundant processes and disparate regulatory systems to accelerate its time to market. Company leaders decided to implement Vault RIM as the single, unified global repository for trusted regulatory data – improving submissions visibility, data quality, and speed.

Driving adoption of a unified RIM platform

Pharming’s change management strategy took a three-step approach to drive Vault RIM adoption, from early in the process to after go-live. Dr. Sadia Chaudhry-Zutshi, associate director, medical writer, global regulatory affairs at Pharming, explained that the strategy focused on:

• Relationship management: Pharming established a cadence with business, IT, and Veeva collaborators to navigate challenging and unexpected situations that come with change. Building and maintaining relationships improved trust and support from stakeholders, leading to faster solutions and better alignment.
• Subject matter experts (SMEs): Implementation stakeholders met with leadership and Veeva collaborators to learn best practices for training and incorporating SMEs. Leveraging video recordings, Pharming scaled training cross-functionally without reducing bandwidth.
• Roles and responsibilities: Pharming determined roles and responsibilities early in the process, redistributing ownership as engagement levels changed. This iterative approach helped progress the implementation when business workloads increased.

Translating change management strategy into action

Pharming focused on stakeholders to understand their regulatory pain points, implementation concerns, and priorities. This allowed for targeted engagement through multi-channel updates, live demos, and meetings to build cross-functional trust and excitement for the new RIM platform.

Dr. Chaudhry-Zutshi highlighted that “change is not something that everyone is comfortable with; I had to understand where concerns were coming from in order to have a successful implementation.”

For a smooth transition, Veeva collaborators held SME training sessions for Vault RIM using preconfigured settings based on best practices. Pharming used recorded sessions as on-demand training material to continue incorporating SMEs in supporting functions. As bandwidths changed to meet business needs, Pharming was able to redistribute roles and responsibilities and seamlessly train internal recruits to keep the implementation timeline on track.

Learnings from cross-functional collaboration

A key factor in the successful implementation and adoption of Vault RIM at Pharming was cross-functional collaboration. Dr. Sadia Chaudhry-Zutshi noted, “If I didn’t build relationships and trust with internal members, they wouldn’t use the system or join the training.”

Dr. Sadia Chaudhry-Zutshi shared learnings for successful cross-functional work:

• Boundaries: Establish boundaries with stakeholders to increase communication efficiency. Set a cadence of emails and calls for key project milestones and information.
• Visibility: Ensure implementation leads maintain high visibility of progress and responsibilities to improve planning and decision-making throughout the process.
• Patience: Increase team alignment and trust by using a patient approach to questions, turnaround times, and implementation feedback.

Pharming currently has over 70 users in Vault RIM using collaborative authoring, submission content planning, and Submissions Archive.

Learn how effective change management increases the uptake and value of a new RIM system with strategies for increasing user adoption.