7 Things to Know About the China Pharmaceutical Industry

China is the second largest pharmaceutical market in the world. Demand is likely to increase as the government introduces reforms to improve the country’s health care system. These changes are helping multinational drug makers tap into the Chinese pharmaceutical market. Synchrogenix’s China Service Line has compiled a list of seven things to know about the China pharmaceutical industry to help you ...

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Implications of FDA’s Decision to Issue Fines for Failing to Submit Clinical Trial Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTri ...

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Updated ClinicalTrials.gov Quality Control Review Criteria

On June 27, 2018, ClinicalTrials.gov posted updated support documents reflecting the current quality control (QC) review process, including review of data elements added by the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) for protocol registration and results information. ClinicalTrials.gov QC Review Process The ClinicalTrials.gov QC review proc ...

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We Checked EPARs for Personal Data and Found It

By Kristin McDougall, Work Stream Lead, Transparency & Disclosure What started as research on a European public assessment report (EPAR) on the European Medicines Agency (EMA) website for a sponsor, quickly turned in to a wide spread transparency and disclosure health and wellness check. With the General Data Protection Regulation (GDPR) in effect, knowing exactly what documents are posted pu ...

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Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no longer apply to the United Kingdom ( ...

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