Industry wide, Patient Support Services Programs are receiving more attention, legal scrutiny and activity from government and other entities. A leading biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases wanted to evaluate its program for risk of litigation and investigations in various areas.
Reviewed and assessed current program documentation and details and created process flows to detail current state of functional areas and responsibilities by stakeholder
Created documentation roadmap including prioritization chart of new program recommendations including timing, level of effort, and potential cost of addressing each
Developed necessary policy and standard operating procedure document for key Patient Services areas and activities
Created training presentations and facilitated for the Patient Services Support group
Following the key stakeholder interviews and associated assessment, Helio rapidly delivered an approach to addressing the missing policy and procedure documents, created the agreed upon documentation, and ensured all necessary stakeholders and team members were trained to ensure the mitigation risk of non-compliance with internal policies and external regulations.