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.

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Accelerator Methodology Delivers Validated Oracle Argus Cloud in Record Time

Posted May 2nd, 2017 Technology Services

Susan Najjar
Director, Marketing

Many small, medium and large sized organizations have their safety data in disparate systems, and as a result this makes it difficult to access and view their data, make informed decisions, and manage reporting to regulatory authorities. Due to growth through mergers...

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Market Access and the Importance of Value Based Pricing

Posted April 20th, 2017 Real World Evidence & Market Access

Dr. Chitra Lele
Chief Scientific Officer

[This is the second post in a three part series that discusses and to a certain extent demystifies the phenomenon that is Real World Evidence (RWE) and its influence on the product lifecycle. This post focuses on Market Access and its scope,...

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Real World Evidence: An Emerging Phenomenon

Posted April 6th, 2017 Real World Evidence & Market Access

Dr. Chitra Lele
Chief Scientific Officer

[This is the first in a three part series that discusses and to a certain extent demystifies the phenomenon that is Real World Evidence (RWE). This post focuses on Real World Data (RWD) and how it can effectively supplement clinical trial evidence...

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Three Things to Remember when Writing an Engaging ‘Discussion’ in a Biomedical Manuscript

Posted March 9th, 2017 Regulatory Affairs Blog

Soma Das
Assistant Manager - Medical Review

The discussion section of a biomedical manuscript is an opportunity to present new research outcomes (including clinical trials outcomes) and their implication to science, or a new perspective on what is already known on the subject and how it impacts future outlook....

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Reporting of SUSARs Based on Aggregate Analysis – Statistical Considerations

Posted January 24th, 2017 Clinical Development and Post Approval Support Services Blog

Michael Zelasky
Principal, Global Biometrics

In December 2015, the FDA released the draft guidance Summary of Assessment for IND Safety Reporting1. The draft guidance includes recommendations on reporting of SUSARs (Serious and Unexpected Suspected Adverse Reactions) based on aggregate analysis. Aggregate analysis is stated in the Code...

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