Clinical Research Solutions
Clinical Trials in the Midst of COVID-19, Part One: European Medicines Agency (EMA)
Disclaimer As of April 23, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these...
Clinical Research Solutions
Rapid and Responsive Implementation the Right Way
During the COVID-19 global pandemic, Medical Information (MI) and Pharmacovigilance (PV) teams are providing an extremely valuable service to deliver current and accurate product information to...
Clinical Research Solutions
Understanding the New Combination Product PMSR Guidance Documents and Impact on Industry
On March 20, 2018, the US Food and Drug Administration (FDA) released two new guidance documents to help companies comply with the December 20, 2016 final rule establishing postmarketing safety...