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Compliance Program Assessment and Enhancement

 

HELIO’s Compliance Program Assessment and Enhancement services focus on crafting best-in class Compliance Programs. This includes creating Compliance Programs for companies who are in a pre-launch phase and assisting established Life Sciences companies with a risk/gap assessment of their current program and optimizing their program to mitigate risk. Now, with HELIO AI, you can identify Compliance-related questions and get real time answers regarding HCP interactions.

 

Services Include:

  • Program Creation (Pre-Launch)

  • Risk/Gap Assessment

  • Program Optimization & Risk Mitigation 

CASE STUDY:

Ramping up RAMP

  • CHALLENGE

    A mid-size biopharmaceutical company wanted to conduct a refresh of its Risk Assessment Mitigation Plan (“RAMP”) to help its Legal and Compliance teams identify, assess, and prioritize areas of potential compliance risk to the Company.

  • APPROACH

    To conduct the RAMP, Helio performed the following:

    • Interviewed numerous company stakeholders across different business functions to identify areas of risk relative to specific business processes and overall legal and compliance risks.

    • Compiled findings in a RAMP tool to identify the key areas of risk exposure for the Company and scored each risk area based on the level of existing controls and the level of potential impact to the company to generate an overall risk score.

    • Discussed results with the Company’s Legal and Compliance teams and implemented processes to mitigate key risks.

  • IMPACT

    As a result of HELIO’s work, the client received a comprehensive risk mitigation plan to address potential Legal and Compliance risks specific to the different business functions and the Company’s unique operating model. The client was able to integrate the identified risk areas into its annual monitoring and auditing plan and enhance existing processes by tightening controls and increasing communications and training.