Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...
Due to the current regulatory landscape that has been created by the COVID-19 pandemic, clinical trials have been disrupted across the globe. To many Sponsors, this may feel like a loss of progress...
As a response to the COVID-19 Pandemic, the US Food and Drug Administration has recently issued a new guidance document for industry, investigators and institutional review boards titled “FDA...
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...
The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...
As of March 27, 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 recommendations...
The outbreak of COVID-19 (coronavirus) in the United States has significantly impacted our lives in virtually every way. For pharmaceutical and medical device firms, one of these impacts came on...
Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will continue to guide you through all these recommendations and...
Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will try to guide you through all these recommendations and...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...