Blog Posts with Tag: Clinical Studies

The Spirit of GLP
A Best Practice for IVDs
Tuesday, June 17, 2014
The Case for Risk-based Monitoring
Better the devil you know...
Thursday, June 05, 2014
Immediately in Effect Guidance
In your role as a regulatory professional, chances are you have faced this situation
Tuesday, April 22, 2014
Risk-Based Quality Management of Clinical Trials
US and EU take (somewhat) similar approaches
Friday, January 31, 2014
New Standards for Influenza Tests
FDA moving the bar up for performance
Friday, September 13, 2013
The Call for Greater Transparency in Clinical Trials
Transparent isn't necessarily clear
Tuesday, September 10, 2013
The Sunshine Act Final Rule
Healthy Transparency, But Will It Change Anything?
Wednesday, July 03, 2013
A CDISC Primer
What is CDISC, and why should I care?
Friday, April 12, 2013
Reviewing the Draft Guidance on IRB Responsibilities
It's so succinct it almost fits in a Tweet!
Wednesday, February 20, 2013
Acceptance Criteria Top 10 List
From the home office in Redwood Shores, CA
Wednesday, December 12, 2012
Exploring Bias
An ongoing adventure for a non-statistician
Wednesday, November 14, 2012

Recent Blogs

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!