Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
Compliance challenges, evolving rules and regulations, building a data-driven compliance program, and false claims that lead to indictment and penalties continue to be trending topics in the world of compliance. The Department of Justice (DOJ) recovered over $3 Billion from the False Claims Act case in the fiscal year 2019. Of the more than $3 […]
Data-driven compliance solutions have proven their viability and effectiveness in the world of life science compliance over the years by enabling compliance professionals to mitigate critical risks and significantly reduce pressure. Whether it is identifying red flags associated with engaging HCPs, pinpointing errors in an aggregate spend report prior to CMS submission, or monitoring compliance […]
The design of a compliance program determines its effectiveness in preventing and detecting compliance risks, i.e., misconduct, breach of internal policies, or the policies imposed by the government. It is responsible for determining if the corporate management is enforcing the program or is tacitly encouraging employees to engage in misconduct. This is one of the […]
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 […]
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