This deviation category is confirmed to impact an API, drug substance, drug product, combination product, or medical device with a probability that the rights, safety and/or well-being of patient(s) or trial subject(s) have been compromised.
What is a critical deviation?
These portals are used for scheduling appointments and final drug product receipt.
What are the clinical and commercial portals?
He's not great with paperwork or boundaries, but this regional manager would definitely go all-in to make a site feel special- maybe too special.
Who is Michael Scott?
This is the first step required to initiate commercial onboarding for a site.
What is a fully executed CDA?
A rich guy with a boat freezes while his girlfriend hogs a door.
What is Titanic?
This system is used to log deviations, actions, effectiveness checks, etc.
What is Veeva?
This is the most commonly reported portal issue.
What is a password reset request/login problems?
This character from The Devil Wears Prada could manage any team, but might need a refresher on "positive tone" in emails.
Who is Miranda Priestly?
The portal used to track onboarding progress.
What is Salesforce/GPS?
Group of friends ruin an island vacation with bad decisions and dinosaurs.
What is Jurassic Park?
This is the most common deviation category from aph sites.
What are packaging deviations?
This is where sites can find the current MNC collection procedure in the apheresis portal.
What is the "resources" tab?
Known as the "fixer," aph sites could count on this account manager to handle any issue before it becomes a crisis.
Who is Olivia Pope?
This is the team responsible for verifying SLIF A completion.
What is the Master Data Team?
Superhero billionaire uses his money to beat up the mentally ill.
What is Batman? (any version)