The Cytel Blog: Perspectives on Enquiry & Evidence

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

Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance..

For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification..

I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B..

Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical..

ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving..

As we all continue to take necessary precautions against the spread of COVID-19 virus, this year again the CDISC EU..

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...