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.

Clinical Trial Outsourcing to Emerging Markets and Risk Based Monitoring

Yashesh Mehta

Global Outsourcing Trend: Global Pharma companies need to continually innovate to find better, cost efficient and regulatory compliant solutions to control research costs and remain competitive. These companies thus leverage global resources by outsourcing services to service providers, both full-service CROs as...

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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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Dr. Chitra Lele, Chief Scientific Officer, Sciformix

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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