Newsletter - February 23, 2017
EMA Raises Concerns with Use of Electronic Systems in Clinical Trials
Auditors from the European Medicines Agency (EMA) frequently find several issues with the implementation and management of electronic systems used in clinical trials such as randomization systems, supply management, eCRF and eTMF. EMA recently released a list of common audit findings and suggested solutions related to the use of electronic systems. Read More
Small Companies Use Smart Strategies to be Successful with FDA
Small drug companies with limited resources have become increasingly smart at using innovative strategies to get market approval for their products by FDA according to a review published earlier this month. The review, co-authored by FDA personnel, lists four major strategic approaches that lead to positive NDA or BLA decision for the product.. Read More
EMA Raises Concerns with Use of Electronic Systems in Clinical Trials
Auditors from the European Medicines Agency (EMA) frequently find several issues with the implementation and management of electronic systems used in clinical trials such as randomization systems, supply management, eCRF and eTMF. EMA recently released a list of common audit findings and suggested solutions related to the use of electronic systems. Read More
Small Companies Use Smart Strategies to be Successful with FDA
Small drug companies with limited resources have become increasingly smart at using innovative strategies to get market approval for their products by FDA according to a review published earlier this month. The review, co-authored by FDA personnel, lists four major strategic approaches that lead to positive NDA or BLA decision for the product.. Read More
