Tag Archive: data standards

Jan 11 2013

FDA’s Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

Continue reading »

Jan 11 2013

FDA's Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

Continue reading »

Nov 19 2010

Download the Slides from the Data Quality and Integrity Webinar

Yesterday’s free webinar, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval,” was a great success!  For those who would like them, the slides from the presentation are now available for download here (PDF file). Stayed tuned Ask-Cato.com for details on our upcoming webinars! Related articles: Introduction to Good Clinical Practice Webinar Slides (ask-cato.com) …

Continue reading »

Nov 05 2010

Data Quality and Integrity: From Clinical Monitoring to Marketing Approval

At 2:00 PM ET on Thursday 18 November 2010, Cato Research will host a webinar titled, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval.”  The webinar will be presented by Nancy Detich, Ph.D., a Senior Clinical Strategy Scientist from our office in Montreal, Canada.

Continue reading »

Oct 07 2010

Improving Assessment Data Consistency in Multi-Center Studies

Ensuring assessments are conducted, analyzed, and reported consistently across sites is a challenge facing managers of multi-center clinical studies.   While identification and quantification of between site variation is typically part of the statistical analysis, collecting more consistent data from the outset leads to cleaner results.  Although an issue for all clinical studies, the impact is …

Continue reading »

Jun 18 2010

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

Continue reading »