Your product is ready to advance from vision to execution – but how prepared is your organization?
As a company transitions from an R&D focus to commercial operations, they need an organizational operating model – one that is expertly designed and implemented in order to be sustainable. The three questions most often asked are:
"We have a great product... but how is the organization itself going to commercialize?
"Do I have the right people, capabilities, and access to information in place for launch?"
"Which investments do I need to be successful and how do I manage risk?"
Your product needs to reach patients on your timeline, and Organizational Readiness is a critical step in the journey to commercialization. We help you define what “ready” means: from establishing new functions and implementing dozens of processes, to choosing fit-for-purpose systems to support the data you need. We focus on stakeholder alignment while minimizing disruption and learning the complexities of your business well before making recommendations, putting you in the best position for success.
At this stage of the commercialization journey you’re within 2 years of FDA approval. You’ve moved past the initial commercialization readiness phase and are now ready to start identifying and implementing systems as well as the proper security that goes with them.
What you should be focused on at this stage of the commercialization journey:
This process guides the organization or function(s) through identification and alignment on the business capabilities needed for launch and provides a clear perspective of what "good" looks like. A well-designed plan ensures the team can stay focused on business outcomes and is not encumbered by the applications “shopping list".
Sound decision-making is essential throughout the launch process, much of which is informed by data. Our strategy identifies the data needed to make decisions across your organization, as well as how that data can be sourced. We then create a seamless implementation plan to enable timely, accurate, and secure data access.
An ERP is the heart of your corporate operations, recording the activities of the business and reporting to both internal and external parties. Leveraging decades of ERP expertise, we assist with the requirements and definition of business processes needed to support a commercial company, as well as the selection, implementation, and ongoing management of the business systems and/or partners to support those key processes.
Making fact-based decisions quickly is critical in an evolving company and market. SVA provides thought leadership and industry knowledge in support of your analytics implementation, whether the target is clinical, medical, commercial or the organization as a whole. From advising, to orchestrating or developing analytics, our process de-risks the analytics implementation while collaborating with you to focus on business questions and outcomes that are the most important.
Ensuring that technology empowers your organization rather than holding it back is a key concern for any business. Without the right technology, skills, and capabilities, we see business leaders creating workarounds, silos, or worse, getting hung up on gaps rather than focusing on launching their product. To ensure you're ready to advance, we evaluate IT maturity both qualitatively and quantitatively, providing a comprehensive analysis of what you need most to be successful.
Transitioning from an R&D focus to a commercially operating company requires a shift in the IT infrastructure to support it. Introducing a remote and distributed workforce, a greater network of external partners, new compliance requirements and a greater scale of activity requires a strong technology footprint to ensure your technology remains an enabler of the business. SVA's Collaboration Accelerator is a templated and packaged approach to powering your workforce easily and quickly.
Despite broad impact, Medical Affairs’ non-promotional nature coupled with the (seemingly) intangible subjectivity of their work continues to present significant challenges in realizing and substantiating their value. Designed to directly confront these challenges, our organizational strategy and planning methods enable Medical Affairs to effectively plan, execute, and manage their objectives in a way that is easily communicable from an impact and value perspective.
Preparing your organization for launch can be demanding, and situations may arise where it makes sense for certain functions and processes to be supported externally. Business Process Outsourcing (BPO) can reduce financial risk, minimize disruption, and allow staff to focus on other activities requiring their attention. Our BPO team is highly committed, flexible, and experienced in emerging life science administration and improvement and can fill the gaps in your organization without interruption.