Perspectives on Enquiry & Evidence

In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after..

Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC..

The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of..

As of today, our Industry has not defined any approach, nor does an official regulatory agency..

In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...

The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a..

Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..

The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all..

About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO..