Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
“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 […]
As the Life Sciences industry evolves, the significance of robust data collection processes cannot be overstated, especially when submitting open payment data to the Centers for Medicare & Medicaid Services (CMS). With regulatory scrutiny on the rise, organizations grapple with the complexities of ensuring their spend reporting practices align with the ever-evolving compliance requirements. As […]
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