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.

Dr. Suhasini Sharma

Safety & Risk Management for Biosimilars : Biosimilar Naming


Dr. Suhasini Sharma

Naming can have important implications for traceability/identification and safety monitoring for biosimilar products. This is currently a hotly debated topic across the biopharmaceutical industry. While some have advocated assigning unique nonproprietary names to biosimilars, there is an equally strong viewpoint on using...

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EMA Launches Medical Literature Monitoring Services: To improve the safety monitoring of medicines by enhancing the quality and consistency of data


Prashant Joshi

On 12th May 2015, European Medicines Agency (EMA) released official notification of their new service, MLM (Medical Literature Monitoring). EMA has published the list of active substances and a reference to the journals that will be covered by this new service. This...

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Five Steps to Sustain and Optimize Effective Delivery of Statistical Programming Services in a Globally Distributed Model


Dr. Chitra Lele Ph.D.

Several best practices when outsourcing and offshoring clinical research related activities are well known, especially to companies that have been doing this for a number of years, though they may be applying these to varying degrees. Practices such as defining clear communication...

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Clinical Trial Data Analysis – Does A Globally Distributed Model Through Outsourcing and Offshoring Help Biopharmaceutical Companies and How?


Dr. Chitra Lele Ph.D.

Over the past decade BPOs, KPOs, SPOs and CROs have been instrumental in addressing industry challenges by providing clinical development services such as clinical operations, clinical data management, pharmacovigilance, regulatory operations, statistical programming and analysis and medical writing1. Amongst these, the domain...

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