Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
The life sciences industry is subject to stringent regulatory requirements and constant scrutiny, making compliance a critical yet challenging aspect of operations. Traditional methods of compliance management, often characterized by manual processes and retrospective audits, are no longer sufficient to keep pace with the dynamic regulatory environment. To overcome such challenges, the integration of Artificial […]
The new era of regulatory enforcement demands companies and compliance teams to stay ahead of the curve by leveraging cutting-edge AI technologies designed to identify, manage, and mitigate risks while assuring compliance. One such technology that is making significant strides in making access to data as convenient as possible is chatbots powered by generative AI, […]
“48% of compliance teams are turning to big data and analytics to strengthen their compliance function.” (Source: Compliance Risk Study – 2022 | Accenture) Data forms the foundation of every successful compliance program. This fundamental concept is straightforward: Companies develop success metrics backed by data to assess the effectiveness of their compliance efforts. Life sciences […]
Commercial compliance programs serve as the foundation of organizational integrity, ensuring adherence to all applicable rules and regulations specifically related to the company’s commercial activities. From the U.S. Department of Justice (DOJ) compliance mandates to the Office of Inspector General’s (OIG) enforcement-centric stance on third-party engagements, commercial compliance programs are designed not just for regulatory reporting but for […]
In the life sciences industry, ensuring regulatory compliance and effectively managing risks associated with healthcare professional (HCP) engagements are crucial. Recognizing that it is impractical to audit or monitor every interaction with HCPs, compliance teams need to use a risk-based approach to prioritize and focus on activities with a higher risk of compliance issues. Artificial […]
The U.S Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) on November 6th – 2023, for life sciences companies and other industry verticals. The GCPG follows an earlier announcement by the OIG, which was associated with modernizing compliance programs. It also contains a few […]
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