Clinical Research Solutions
How quickly the auditing landscape has changed! Less than one year ago if ProPharma Group were asked to perform a clinical audit on your firm’s behalf, we would reply with “when, what, and where?”...
Clinical Research Solutions
On July 21st, 2020, the FDA released a draft guidance document for developers of cannabis and cannabis derived compounds, aptly titled “Cannabis and Cannabis Derived Compounds: Quality Considerations...
Clinical Research Solutions
Are you using Microsoft Excel spreadsheets for GxP activities? Are these Excel sheets used again and again, as a template? Ever thought about validating your spreadsheet templates? Is the person who...
Clinical Research Solutions
On Friday, July 11th, Stephen Hahn, MD, Commissioner of the FDA, issued a Coronavirus (COVID-19) Update, announcing the Agency's plans to resume "prioritized domestic inspections of FDA-regulated...
Clinical Research Solutions
The COVID-19 pandemic revealed a structural weakness in many products’ supply chains. In terms of supply of pharmaceutical products, supply shocks were not mitigated when intermediates or production...
Regulatory Sciences
When conducting a clinical trial, there are many aspects sponsors need to be aware of with regards to clinical safety, product efficacy, and the ability to bring treatments through the multiple...
Clinical Research Solutions
On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The...
Clinical Research Solutions
The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
Clinical Research Solutions
A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in...
Clinical Research Solutions
In the first blog of this three-part series, “Overlooking Your QMS Could Cost You,” we discussed the cost of “good” versus “poor” quality, and the importance of investing in a “good” Quality...