Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
The U.S Department of Justice (DOJ) updated its compliance program evaluation guideline outlining exactly how it evaluates corporate compliance programs. The new guidance instructed prosecutors to ask life sciences companies’ compliance teams whether they have data sources for timely, effective, and efficient monitoring and whether they are continuously testing and updating policies, controls, and transactions. […]
The answer to “is managing compliance really that difficult?” is that it is and isn’t at the same time. To understand this, we must look beyond conventional compliance practices, evaluate factors influencing compliance positively or negatively, and determine what makes compliance difficult and how companies can reduce the pressure. So, let’s explore both sides to […]
Life sciences and pharmaceuticals operate in a highly regulated industry, and one of the most challenging aspects of operating in this industry happens to be complying with the rules and regulations imposed by the government. In addition to the rules and regulations, let’s talk about the evolving nature of regulatory requirements. The heightened expectations and […]
Monitoring is the ongoing evaluation of business activity taking place, working as intended, and expected outcomes occurring. If your current compliance monitoring program does not align with this definition, it’s better to reevaluate the program to ensure it aligns. Other than ensuring a high level of comfort, a well-designed compliance monitoring program provides highly valuable […]
Compliance in 2024 is at a crossroads and life sciences companies are facing critical decisions that will shape their future direction in response to the evolving regulatory demands. Companies have had success in implementing the ‘7 Elements.’ However, very few have had success in developing an AI-driven compliance monitoring program. Advanced compliance monitoring in life […]
Meeting the federal and state aggregate spend reporting requirements demands significant time, resources, focus, and strategic processes from a life science organization. The evolving nature of the requirements and expectations set by the CMS make it extremely difficult for life science companies to comply with them, let alone monitor and stay updated with changes to […]
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