Defining an ERP Readiness Plan to Support Clinical and Commercial Operations
This client is a biotechnology company focused on the discovery and development of therapies for patients with neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, ALS, and others. As the client prepares to launch its first commercial product, they are looking to define a strategy that will enable the cross-functional use of SAP for supply chain capabilities and manufacturing of both clinical and commercial products.
The organization engaged our team to create a robust ERP readiness plan for their SAP implementation that identified the necessary critical activities as well as the timing and sequence of events. Our team assessed the client’s current state processes and capabilities, identified gaps in cross-functional capabilities when compared to similar life sciences organizations using SAP, and highlighted key observations, considerations, and decisions to prepare them for commercialization and the use of SAP.
We engaged with 20+ business leaders to understand existing business processes for Supply Chain, Procurement, Quality/Regulatory, Finance, and Manufacturing. Working sessions focused on current state capabilities, the use of technology, and future state requirements for clinical and commercial products. Following these sessions, our team created a Supply Chain Roadmap and Capability Matrix that defined all cross-functional activities required to support commercial products, provided key observations and considerations when building business processes, and made recommendations for key decisions that would impact their use of SAP.
As part of their ERP readiness plan, the client anticipated deploying a “Big Bang” approach for their implementation. To ensure the client understood the pros and cons of this type of deployment approach, our team shared two additional SAP deployment approaches and outlined the benefits and risks for each option, along with the estimated business resource requirements. Each deployment option needed to consider business processes and capabilities that must be established (in addition to implementing SAP) to support a commercial launch.
We also recommended additional ERP readiness considerations, including high-level program activities that will need to be considered for the SAP implementation, such as business readiness, project management, computer systems validation, organizational change management, and training.
DOWNLOAD THE CASE STUDY BELOW.
This case study was originally published by a partner in our business ecosystem, Clarkston Consulting. Learn more about Clarkston here.