Don't use FDA Form 3455 to collect financial disclosure information from clinical investigators
Consistency, clarity, and completeness in version histories
Living in a permanent state of disaster recovery means relying on the "quality cycle" - plan, execute, oversee, and improve - rather than regulatory "dos and don'ts."
How many people should be on a GXP inspection team?
ICF versioning is rarely straightforward, but these tips can help you identify missing documents.
Bridging the GMP/GCP communication gap
Why sponsors need to be prepared to respond to questions during clinical site inspections
How attributable and contemporaneous do clinical trial records need to be?
Caleb Barlow, CEO of CynergisTek, explains why the pandemic has made clinical trials even more vulnerable to cyberattack.
Confirm that all expected documents are on file for both independent and internal committees.
Use cross-checks to identify missing plans
QCing a TMF is like cleaning a database
Risk ranking is the classic way to evaluate risks, but does it add value?
Multiple enhancements designed to help you understand the inspection as a whole
A quick explainer on the differences between correction, corrective action, and preventative action
It's OK to volunteer a little more than name, rank, and serial number during inspection interviews
These magic phrases can help you find your footing during an interview
When preparing for inspection, use your resource wisely