A biopharmaceutical company with limited Compliance support and resources, contacted HELIO to evaluate its Patient Support Programs to ensure compliance with Company policies as well as federal laws and regulations.

• Reviewed and assessed current Patient Support Program documentation (e.g., patient consent process, enrollment forms, call notes, authentication logs, etc.) to create audit parameters and checklists to test processes and data governance along the patient journey.

• Conducted a transactional monitoring review of call notes documenting the full Patient Journey for sampled patient cases, starting with the patient onboarding process to ongoing treatment plan management, on a selected sample set of patient cases.

• Reviewed the de-identified patient data strategy and security structure of the data warehouse to ensure compliance with data privacy and protected health information industry standards.

• Reviewed patient support calls managed by a third-party vendor to ensure compliance with company policies, procedures, and call scripts.

• Discussed observations, compliance enhancement recommendations for the Patient Services Program, and recommendations to improve the patient security structure with the company’s Legal and Compliance Team.

As a result of HELIO’s work, the client received a comprehensive risk analysis of the current state of their Patient Services Program along with operational recommendations to current systems, processes, and IT security structures based on industry best practices.