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What our customers say
"The ADaM datasets … are some of the finest I have ever seen constructed in my career. Very clean and very easy to work with… Thank you!"
James R. Johnson, PhD
(Formerly) Sr. Director Biostatistics and Data Sciences
Flexion Therapeutics, Inc.
Cytel's CDISC team includes an authorized CDISC instructor and other experts who keep up to speed with the ever evolving standards.
With CDISC experience across many therapeutic areas (including a strong experience in oncology) we are dedicated to providing high-quality SDTM and ADaM datasets and have a dedicated CDISC implementation team.
We ensure the full compliance of datasets and supporting documentation (Define files and Reviewer Guides) and have a 100% first time acceptance rate for all SDTM datasets submitted to the FDA.