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Safety and Medical Monitoring

Our medical monitors provide feedback on protocols and are on call 24/7 to respond to protocol related questions.  They also routinely prepare and submit serious adverse event reports to regulatory agencies, provide medical review of outcomes and assist in final report writing.

Drug safety and pharmacovigilance risk management during pre-approval and post marketing phases of a compound’s life-cycle has gained increasing attention in the media after some recent drug withdrawals and subsequent regulatory tightening.  At CMX Research Inc. we recognize the importance of identifying and assessing risk during clinical trials so that the safety profile of a drug is accurately captured.  CMX Research Inc. has designed and executed many successful Phase IV trials that have contributed to the safety profiles of our client’s products.  The safety processes and medical monitoring is carried out by licensed physicians who are trained to provide appropriate oversight to every study.   

Our drug safety and medical monitoring team is responsible for the collection, evaluation, analysis, and reporting of safety information from our clinical trials.  This includes serious adverse events and other significant safety events; narrative writing, medical coding of adverse events (MedDRA, WHO Drug), preparation and submission of global safety reports (internal or MedWatch/CIOMS for regulatory submission), preparation of alert letters (Dear Doctor), post-marketing surveillance reports and Periodic Safety Update Reports (PSURs).