Blog

Sciformix is committed to sharing ideas and insights with the life science industry and support the development and commercialization of safe and effective products. Our employees and partners share their knowledge and thought leadership.

Soma Das, Assistant Manager, Medical Review

Good Publication Practice 3 (GPP3) in Practice: A Road Map to Ethics & Transparency in Medical Communication


Soma Das

Good publication practice (GPP) guidelines advocate clear, timely, transparent and high quality reporting of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. Good Publication Practice 3 (GPP3) guidelines published in August 2015 retain the core values of...

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Prashant Joshi, Director of Domain & Process, Safety and Risk Management at Sciformix Corporation

EMA Announces Release of Updated EudraVigilance System: What this Means to the Industry


Prashant Joshi

On 22-May-2017, EMA announced the go-ahead for their new EudraVigilance system for collection and monitoring of suspected adverse reactions. This was a much-anticipated and awaited announcement following the recent completion of an independent audit of the system. As per the announcement of...

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Dr. Brent Allan, Executive Medical Director at Sciformix

FDAs Guidance on Safety Assessment Committees – Podcast


Dr. Brent Allan

In clinical trials, a comprehensive understanding of the safety profile of the product requires the consolidation of safety data across the same molecule and class. Aggregation and analysis of data are particularly important with the FDAs guidance on Safety Assessment Committees where...

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