Medical Writing

The success of your programs are dependent on high quality documents delivered on-time

 

The importance of having the right level of subject matter expertise, depth of writing capabilities and effective project management oversight, is critical for quality and compliant medical writing. Sciformix provides a full range of medical writing services spanning the spectrum of drug development from pre-clinical to clinical through post marketing activities. We offer standalone and comprehensive end-to-end medical writing service.

– Clinical Writing
– Regulatory Writing
– Medical Information & Communications
– Aggregate Reporting

 

Signal Management and Its Role as a Critical Component of Pharmacovigilance


Mitchell Gandelman

Introduction Signal management is one of the most crucial steps in pharmacovigilance and is defined in numerous guidelines to various degrees (EMA Guideline on Good Pharmacovigilance Practices (GPV) Module IX – Signal Management1, FDA Guidance for Industry, Good Pharmacovigilance Practices and Pharmacoepidemiology...

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David Balderson, Vice President of Global Safety Operations

What is ICSR Quality and How Is It Measured?


David Balderson

In my experience of being in the operational side of Safety for the last 16 years, I have learned that the perception of what ICSR (Individual Case Safety Reports) quality means often varies between the company’s perspective as an MAH (Marketing Authorization...

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Optimizing Global Labeling Operations


Boris Jankowski

From my experience and interacting with labeling professionals around me, I can safely say that 10 years ago labeling development by itself was sometimes very disconnected from the drug development process. When we look back we see a Target Product Profile (TPP)...

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