test44
https://www.cytel.com/blog/the-fda-real-time-oncology-review-process-an-opportunity-challenge-for-sponsors
November 30, 2021
The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of..
Read article
test44
https://www.cytel.com/blog/the-importance-of-traceability
October 5, 2021
Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance..
Read article
test44
https://www.cytel.com/blog/cdisc-certification-is-it-worth-taking
August 31, 2021
For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification..
Read article
test44
https://www.cytel.com/blog/in-a-virtual-room-with-the-fda-reviewers
July 30, 2021
I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B..
Read article
test44
https://www.cytel.com/blog/career-perspectives-interview-with-anil-golla-fsp
July 20, 2021
Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical..
Read article
test44
https://www.cytel.com/blog/practicalities-of-integrating-electronic-health-records-into-the-trial-data
June 14, 2021
ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving..
Read article
test44
https://www.cytel.com/blog/why-you-should-not-miss-2021-virtual-cdisc-eu-interchange
April 26, 2021
As we all continue to take necessary precautions against the spread of COVID-19 virus, this year again the CDISC EU..
Read article
test44
https://www.cytel.com/blog/the-integration-dilemma
March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency..
Read article
test44
https://www.cytel.com/blog/avoiding-lost-in-translation-with-submission-terminology
February 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...
Read article