Are you SEND-ready?

Partner With Confidence.

• A seamless process. Our dedicated SEND team works onsite to ensure your data from collection to submission is accurately converted. With a single point of contact, your SEND expert will be accessible to answer your questions from start to finish.

• Experience. As active members of the CDISC SEND Consortium and PhUSE (Pharmaceutical User Software Exchange) nonclinical working groups, our team contributes to the development of SEND standards and remains at the forefront of these evolving standards to support best practices.

• Rapid turnaround. We understand the importance of your timelines and can prepare submission-ready files within two weeks. Interim datasets are also available for submission or for data warehousing purposes.

What can I expect to receive in my SEND package?

• SAS Transport Files (XPT format)
• Define file (XML format)
• Study Data Reviewer's Guide [nSDRG] (DOC format)
• Additional formats are available upon request

What do I need to know about recent and upcoming changes to SEND?

• Effective March 15, 2019, SEND 3.1 is required for single- and repeat-dose general toxicology, Carcinogenicity studies and Safety Pharmacology studies for NDA, ANDA, and certain BLA submissions.

• Effective March 15, 2020, SEND 3.1 is required for single- and repeat-dose general toxicology, Carcinogenicity studies and Safety Pharmacology studies for IND submissions.