Synchrocast: Understanding Brexit and its Impact on Patients

Synchrogenix's Darshan Kulkarni, Vice President, Regulatory Strategy and Policy, and Nirpal Virdee, Director, Client Services and Technology, talk about Brexit and its impact on patients. Listen in (or read the transcript) to learn more about Brexit, including the reasons behind the binary public referendum put to the United Kingdom's citizens back in 2016, and the outcome of the voting results. A ...

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The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTri ...

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