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Category: Life Sciences Compliance

Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.

Understanding Correlation vs. Causality in Compliance Analysis

In qordata’s most recent webinar, Ned Mumtaz revisited a concept mostly familiar to undergrads and professional statisticians. (And increasingly unfamiliar for the rest of us). The concept differentiated between correlation and causality. Corporate citizens tend to use ‘correlation’ as a blanket term for any variables that seem to have a corresponding relationship. As a compliance […]

Qualitative Concerns in the Life Sciences Transparency/Compliance Environment: Part I

As researchers tend to know, “No response is also a response.” This is an important consideration for compliance professionals, who often rely completely on quantifiable data as the basis for their decisions. To understand the full context behind a compliance metric, it is equally important to go a step beyond the visible and measurable and […]

CMS Reporting Structure Changes for Life Sciences Companies

We’ve written about changes introduced by the CMS in the reporting structure for applicable manufacturers and GPOs about ten months ago. We revisit those today, observing how those changes enable applicable medical drug and device manufacturers in the spend submission process. Data Entry Ease Submitting spend reports for entities overseas? Made R&D payments to HCPs […]

Measuring Compliance with Transparency Metrics

I’ve been reading an excellent paper on introducing, implementing, and measuring the effectiveness of transparency metrics for software systems. And while reflecting on it, I realized that the principles and methodology discussed are applicable for the pharmaceutical compliance space too. While the paper concedes the obscure nature of transparency, it establishes that metrics for transparency […]

Penalties for Failure to Report or Erroneous Submissions in Sunshine Payments

Slightly over two months ago, applicable manufacturers in North America added to the 40.74 million records already present in the CMS Open Payments database. This exercise will also add to the $24.92 billion worth of Transfers of Value (TOVs) already covered in the database since 2013. So why do companies make the laborious effort of […]

The Crucial Role of Technology in Achieving GDPR Compliance

“What Role Is Technology Playing In Helping You Become GDPR Compliant?” We asked this question (or rather, a version of it) during a survey at our recent GDPR Life Sciences Bootcamp. The respondents were uniformly compliance/transparency professionals from the life sciences industry. Any guesses on what their response was? Less than 10% were able to […]