Knowledge Base

More Clinical Trials in China in the Future? February 12, 2018 in Advisories,

The China Food and Drug Administration (CFDA) is moving forward with implementation of several ICH guidelines in order to further the development of innovative drugs and devices in China. Read More

Many U.S. Clinical Trial Sponsors Are Unprepared for New EU GDPR Regulation February 8, 2018 in Advisories,

As of May 2018, U.S. sponsors of clinical studies conducted in the EU must be in compliance with EU's new General Data Protection Regulation or risk possibility of fines. Read More

The Effectiveness of HEPA Filters on DNA NESA January 23, 2018 in White Papers,

Here we determined that DNA is captured by a HEPA filter at the same efficiency as the filter is rated and discovered DNA cannot be dislodged from a HEPA filter. Read More

Best Practices for Randomization and Trial Supply Management (RTSM) January 22, 2018 in White Papers,

Does your organization have guidelines for randomization and trial supply management (RTSM) strategies? Interested in gaining insight from other trial sponsors and industry experts? Read More

Common Rule Implementation Delayed for Six Months January 17, 2018 in Advisories,

The Department of Health and Human Services has proposed a one-year delay in implementation of the revisions to the Common Rule. Read More

Data Curation – the Foundation of Data-Driven Research MediSapiens Inc. January 16, 2018 in White Papers,

Heterogeneity within and between data sets makes scientific analysis significantly more challenging. It is thus imperative that data sets are cleaned up, standardized and harmonized Read More