August 25, 2015
Thomas Wicks | TrialScope
Thomas Wicks | TrialScope
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
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.
Continue reading "Defending Against Third-Party Patient Record Data Breaches: What Compliance Officers Need to Know"
Topic of Discussion
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.
Continue reading "Four Risks Pharma Companies Face"
A UL EduNeering Sponsored Article
The whitepaper for this article is available for free download here: “Top Seven Risks to Consider When Selecting a Life Science LMS”.
Scott Barnard | UL EduNeering/UL Life & Health
Life Science companies operate in a highly regulated industry. With risk mitigation core to their DNA, they must be careful when evaluating an enterprise Learning Management System (LMS) or a Talent Management System (TMS) used in GxP areas. It is critical that these systems meet data integrity standards and are validated against the stringent requirements of 21 CFR Part 11 and EU Annex 11.
We find that, as companies look to harmonize systems and bring in enterprise applications to manage both employee development and qualification training, these projects are increasingly influenced or guided by IT and HR. Since these organizations are not as versed in US and international regulatory requirements and since their training programs do not require a validated platform, the project teams they lead are bringing in vendors and systems that do not support the GxP requirements of their organization. This is putting a lot of pressure on QA to “relax” their standard of validation, putting their organization at a data integrity risk.
Continue Reading: “Performance Gaps in LMS Functionality May Lead to Critical Risk for Life Science Companies.”