Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
Monitoring compliance has become an imperative for life sciences companies. Considering that total penalties from compliance-related violations have crossed over US $50 billion since 2000, it is critical for compliance officers and life sciences organizations to plan, strategize, and implement robust compliance monitoring to detect risks before the regulatory authorities such as the U.S Department […]
“The CCO has a critical role in today’s complex business environment. They play a vital role in protecting the organization from reputational damage and legal liability.” ― Mary Jo White, Former Chair of the U.S. Securities and Exchange Commission (SEC) Who are Chief Compliance Officers? Chief Compliance Officers (CCOs) are tasked with the core responsibility […]
Life sciences companies have been one of the most regulated industries over the past 10 to 15 years, with a significant number of regulatory enforcements in total. In fact, the total penalties from compliance-related violations have crossed over $50 billion since 2000 in the U.S. Prevalent signals in both messaging and actions from regulators indicate […]
In today’s intricate regulatory environment, compliance isn’t just a requirement—it’s a dynamic challenge that demands a data-driven compliance solution. This article explores the transformative power of data in monitoring regulatory compliance within organizations. From adhering to stringent regulations such as the anti-kickback statute to OIG’s special fraud alert to identifying key risk areas within the […]
Chief Compliance Officers (CCOs) play a vital role in ensuring that organizations operate within the bounds of the law and adhere to regulatory and industry standards. They are responsible for leading and implementing effective compliance strategies and programs that mitigate legal and reputational risks. The appointment of CCOs to senior positions within organizations reflects the […]
Regulatory demands for life sciences companies have evolved significantly over the years. In the past, regulations were primarily focused on product safety and efficacy. However, today, regulations also encompass many other areas, such as reporting all transactions to the Center for Medicare and Medicaid Services (transparency reporting), ensuring compliant third-party engagements, and more. Combined with […]
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