A mid-size biopharmaceutical company focused on the development of therapies for patients with debilitating diseases wanted to conduct live and transactional auditing and monitoring reviews to assess risks in various areas.

• To assist with live and transactional monitoring, HELIO interviewed Company stakeholders to understand business activities including frequency of activities, data available, and key risk areas to formulate monitoring and auditing plans.

• Assessed and updated the Company’s current Monitoring Plan based on risk areas identified for review and to ensure monitoring parameters were up to date.

• Created live and transactional monitoring forms based on the Company’s pre-existing policies and procedures as well as industry best standards to ensure robust and comprehensive testing criteria for each activity.

• Conducted live and transactional monitoring reviews to execute against the Monitoring and Auditing Plan and documented observations and findings in new monitoring/auditing forms.

• Due to COVID-19 and the shift to the virtual environment and an increase of email communications, HELIO’s proprietary monitoring software system, HELIO AI, was used to conduct several types of reviews (e.g., email, speaker program, travel & expense) to identify any potential non-compliant interactions.

• Discussed observations from live and transactional monitoring and auditing reviews with the Company’s Compliance team to determine future actions such as training, re-monitoring, corrective and preventive actions, and performance improvement plans.

The Company successfully conducted over 2000 monitoring and auditing activities over eight different functional areas for the 2020 year and was able to uncover areas of higher risk and potential areas for re-training the business. In addition, the Company now has a detailed Monitoring Plan and monitoring and auditing checklists that can be used year after year.