EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update - Major Changes Several major changes are noted in this “Summary of Changes” document, including: Cl ...

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Synchrocast Ep 2: Narrative Writing Challenges and Approach

Synchrogenix's Tatyana Wanderer, Executive Director of Services Operations and Kelly Danyow, Associate Director of Workstream Leads have a combined 15 years of experience leading narrative projects. Listen as they discuss clients' patient narrative writing challenges and needs, and Synchrogenix's integrated and streamlined approach to narrative writing. Listen to the Synchrocast Download t ...

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The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTri ...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