Medical Affairs teams are essential players in a successful launch, in market performance, and in improving patient lives. They translate clinical and scientific data to the medical community and bring valuable insights from the practice setting and key opinion leaders back into the company. On top of this, Medical Affairs must operate required processes compliantly within the business both pre-approval and post-approval. In spite of this, Medical Affairs faces the well-known challenge of stakeholders understanding what they do, and their measurable contribution to the success of a company and its patients' performance, effectiveness and demonstrating strategic value.
We are strong believers in the strategic value of a thoughtfully designed, managed and deployed Medical Affairs function including the MSL field team.
Medical Affairs Assessment & Planning
Medical Affairs Systems and 3rd Party Project Management
Medical Affairs Business Process Outsourcing (BPO)
Our approach centers on developing a fit-for-purpose functional strategy and integrated medical affairs plan with a clear eye on patient success. We rely on our clients’ mastery of the science, and they rely on our mastery of the processes, systems and methods for conducting effective bi-directional exchange of fair, balanced and unbiased data and information with the medical community. Finally, we work with Medical Affairs leaders and their stakeholders to establish clear performance expectations focused on outcomes that ultimately focus on improving patient success.
Assessment and Planning Services:
Our approach to systems and process implementation is focused solely on your business needs. As with our assessment and planning offerings, we act as your thought partner to identify where we fit in to resolve your systems and process needs. Our process includes identifying the problems that need to be solved, gathering business requirements, and applying use cases prior to recommending solutions. We know many of the vendor and 3rd party solution providers and if we don’t, we research and contact them on your behalf. Ultimately, we present sensible solutions and thoroughly evaluate alternatives, enabling you to make well-informed, confident decisions. We also provide onboarding and solution integration as your designee to relieve burdens and ensure your team is empowered, well trained and equipped.
Systems and 3rd Party Project Management Services:
Why outsource business processes? Often, organizations are juggling processes with significant financial/other impact, insufficient staffing support, or lower priority work that will enable focus on higher priorities with delegation. Utilizing BPO can reduce financial or other risks, bring peace of mind that processes are running consistently and efficiently, and can allow staff to focus on activities with greater value-add. SVA has a dedicated BPO team committed to emerging life science process administration and improvement. Our process experts include project managers, business analysts, data analysts, and process operators, all of which can create, improve, document and run processes.
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Verastem was referred to SVA Consulting as a Phase 3 biopharmaceutical company with 30 employees and promising data. SVA was brought in to help Verastem Oncology with the launch planning around the operations and processes, as well as helping to plan all of Verastem’s systems, which prior to SVA, their “systems” were email and a server.Read More
Exact Sciences was referred to SVA Consulting when they were a startup medical device company. In lightning speed of 19 months, Exact Sciences grew from 36 employees to over 700, moving from developing Cologuard, their pre-screening test for colon rectal cancer, to human trials, FDA approval and then to the international marketplace.Read More
MyoKardia engaged SVA Consulting at the end of its Phase 3 program to evaluate the commercial capabilities of their financial systems. The question at hand was whether MyoKardia should take on the implementation of a new ERP system, or whether their current ERP system would support a commercial company.Read More