Founded more than 50 years ago, the client is a multinational diagnostics company, currently serving patients in more than 150 countries. The company is headquartered in the European Union with a large U.S. presence, including multiple U.S. subsidiaries. Their clients range from hospital labs to pharmaceutical manufacturer quality teams to commercial food safety teams.
The company’s U.S. medical affairs function is in its early stages, contending with an aggressively oriented commercial organization while integrating a new U.S.-based team and working alongside an established global medical affairs function.
As a result, key functions within U.S. medical affairs were not yet formalized and important governance documentation (e.g., policies, procedures, etc.) were either insufficient or missing entirely. This led to unclear roles and responsibilities, ineffective internal processes and increased medical-science risk overall. In addition, this created the potential for leaving valuable scientific and medical insights on the table.
Baker Tilly was engaged to first conduct a governance assessment of the U.S. medical affairs function, followed by supplementary implementation work for necessary governance documentation identified during the assessment.
The governance assessment was conducted thorough a documentation review as well as stakeholder interviews with the leadership team of U.S. medical affairs to understand the current state and future direction of the team.
Baker Tilly issued a formal report, summarizing gaps such as:
This report included findings detailing the gaps identified and an implementation roadmap with prioritization and proposed timing of each recommended action.
Following the report, Baker Tilly supported execution of the implementation roadmap, serving as trusted advisors in discussions with other functions, and navigating roadblocks or reprioritizations as they occur.
Baker Tilly has continued to collaborate with the company’s medical affairs function by providing training to the larger U.S. medical affairs team, including topics such as advisory boards and FDA label interpretation as well as supporting evidence generation strategies with the global medical affairs team.
By identifying key gaps in the U.S. medical affairs function, Baker Tilly was able to provide the team with usable policies, processes and other governance documents to formalize key processes and establish mature medical functions.
This, in turn, allows the medical affairs professionals to focus their expertise – furthering the medical and scientific objectives of the organization.