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Four Disclosure Compliance Risks that Clinical Trial Sponsors Should Identify and How to Avoid Them


Trial disclosure regulations around the world continue to evolve, are not well harmonized across jurisdictions and can be fairly complex.  There are over 40 countries or regions with mandatory trial disclosure regulations and over 30 trial registries for posting clinical data.  While trial sponsors have developed policies, processes and systems to address key trial disclosure requirements, few have evolved systems for continuous monitoring of trial disclosure and registry requirements, or have the systems to monitor and harmonized disclosure of trial information globally. Four practices in particular rise to the surface as major risks for trial sponsors regarding current and ongoing compliance. Continue reading "Four Disclosure Compliance Risks that Clinical Trial Sponsors Should Identify and How to Avoid Them"

In The Headlines

Telerx

Defending Against Third-Party Patient Record Data Breaches: What Compliance Officers Need to Know


These days it seems as if large corporations, government agencies, insurance and life sciences companies experience breaches on a disturbingly frequent basis. Not only do these information thefts result in direct losses by the breached entity as a result of fines and damages, their reputations and consumer confidence levels can take a serious hit. A study from the Ponemon Institute found that data breaches cost the healthcare industry $6 billion a year. Additionally, about half of healthcare organizations surveyed by Ponemon said they didn’t have sufficient technology to prevent or quickly detect a breach, or the personnel with the necessary technical expertise.
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Topic of Discussion

Bracewell & Giuliani

Four Risks Pharma Companies Face


The pharmaceutical industry, like many others, has faced increased legal challenges and regulatory oversight as it has expanded into emerging markets and it has confronted additional risks associated with technological advances. In recent years, pharmaceutical companies have paid hundreds of millions of dollars to resolve Department of Justice (“DOJ”) investigations, seen employees charged in criminal cases around the world and have been besieged by faceless aggressors seeking proprietary information.  Here, we detail four of the biggest risks facing pharmaceutical companies today: cybersecurity, global corruption, fraudulent marketing, and government scrutiny of potentially anticompetitive conduct that could violate antitrust laws.
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