Learn how USDM helped an emerging biotech client to implement their Veeva RIM Regulatory Submissions Vault to ensure compliant workflows and maximize their IT investment.

Emerging and startup companies typically do not have the IT resources or deep regulatory domain expertise needed to ensure flawless implementation and adoption of their technologies. USDM can significantly help reduce your implementation and validation time while decreasing the cost to manage cloud compliance. Additionally, we can provide the resources necessary to ensure that your projects are properly managed on-time and on-budget based on decades of life sciences best practices.

The Situation
  • An emerging clinical-stage, Phase-1, biotechnology company
  • Less than 150 employees
  • The client was replacing a legacy application and needed support with the implementation and validation of the GxP workflows for their regulatory submission process
  • The client needed continuous cloud compliance support managing Veeva's regularly scheduled updates and releases
  • The client required a high performance team and project management services to accelerate and enable commercialization activities
  • Additionally, the client needed organizational change management to ensure adoption across the organization
The Solution
  • USDM was selected for the project due to our Veeva expertise
  • USDM assisted with the implementation and validation of the end-to-end workflows for the regulatory submission process in an accelerated timeline
  • USDM managed the client's project team to ensure the client's regulatory compliance requirements were delivered correctly and on-time
  • Despite the client team being displaced due to the COVID-19 remote working mandates, USDM was able to keep all stakeholders aligned
  • USDM was also able to pivot quickly and deliver all necessary system  training requirements virtually
  • Furthermore, USDM provided virtual organizational change management training to the key stakeholders and systems users to drive faster adoption
  • USDM achieved end-to-end compliance for the client's Veeva Regulatory Submissions Vault implementation and continues to handle the client's change management with every Veeva update to ensure continuous compliance  
Learn more about USDM’s emerging and precommercial expertise here.
 

Precise execution and implementation for GxP workflows and uses

On-time and on-budget despite COVID-19 business continuity disruptions

Relieved the burden of change management for Veeva updates

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