Clinical Trials Sponsors and Sites Come to Terms with Medicare Reporting Law

Section 111 of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) of 2007 impacted both clinical trials sponsors and clinical trials sites, but as awareness and compliance among the Pharma 15 has grown, the pharmaceutical industry has adjusted and trial sites are becoming more accustomed to providing the required patient information. This article will address both the sponsor’s requirement to report and the impact and advantages to clinical trial sites of reporting.
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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. [Read more…]

Finally: Clinical Trial Speed and Quality

Clinical operations quality control is a major issue in today’s Life Sciences market. The current method of getting drugs and medical devices through the clinical trial process is broken because of a lack of process transparency and data holes. According to CenterWatch, 86 percent of clinical trials experience delays, due to a data quality gap. Additionally, under 10 percent of clinical trials are completed on time. The root cause: poor data quality that slows down results and go-to-market. Old processes will no longer work and Life Sciences companies need to embrace the power of new technologies to modernize clinical trials.
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