<< OUR SERVICES

Transparency and Disclosure

 

Transparency and disclosure laws were created to increase transparency of the financial relationships between healthcare professionals and organizations and the pharmaceutical industry. Initially started in several states in the U.S. and expanded federally, these disclosure requirements have expanded globally and made into law and/or incorporated into country-specific industry codes. HELIO helps companies navigate the operational complexity of aggregating data related to expenditures and ensuring thorough and accurate reporting of these relationships.

 

Services Include:

  • Global & U.S. Transparency Reporting

  • Program Optimization & Implementation

  • Data Verification

  • HCP Dispute Process & Resolution

  • Policy & Procedure Development

  • Assistance in Manufacturer & Field Force Annual Registration & Licensing Requirements 

CASE STUDY ONE:

Compliance Meets Transparancy

  • CHALLENGE

    A leading pharmaceutical company tasked HELIO with managing the development of a Global Data Warehouse for the purpose of triaging data from internal source systems and third-party vendors. The company sought to leverage data to enhance Compliance monitoring initiatives and gather advanced insights on their relationships between healthcare professionals (“HCPs”) and healthcare organizations (“HCOs”).

  • APPROACH

    • Interviewed internal stakeholders to identify relevant source systems, business rules and technical requirements.

    • Created requirements and specifications documentation for implementation.

    • Constructed Data Architecture and schema for standardizing source data.

    • Developed and managed implementation plan and timelines.

    • Perform user acceptance testing of requirements.

  • IMPACT

    By identifying and documenting the necessary rules and requirements, the company was able to efficiently design and develop a robust Global Data Warehouse to meet Compliance monitoring and Transparency reporting needs.

CASE STUDY TWO:

See your Way to Success

  • CHALLENGE

    A multinational biopharmaceutical company, in preparation for commercialization of their product, engaged HELIO to assess and enhance their U.S. transparency program to ensure adequate preparedness of all associated systems and resources to ultimately facilitate accurate and complete report submissions to applicable U.S. federal & State jurisdictions.

  • APPROACH

    • Conduct exhaustive assessment of Transparency relevant systems, resources, and functional areas.

    • Verify data sources and types of expenditures provided to healthcare professionals (HCPs) and healthcare organizations (HCOs).

    • Develop business and technical requirements to enhance system functionality and Transparency related processes.

    • Assist in development and user acceptance testing of identified system and program enhancements.

    • Create all necessary policy, procedural, and instructional documentation.

    • Develop change management material and conduct necessary trainings.

    • Compile all applicable Federal and State Transparency reports and facilitate submissions via the required submission outlets.

  • IMPACT

    Having ensured the overall preparedness of their Transparency program, the client has the necessary systems and protocol in place to continue meeting all reporting requirements even as they continue to grow their product portfolio and expand their business model.