SEND
Standard for Exchange of Nonclinical Data
The FDA's format for nonclinical data
SEND stands for the Standard for Exchange of Nonclinical Data, and the FDA's eCTD requires all nonclinical data to be submitted in SEND format.
Big Data Build
Fast Data Review
Data Reconfirm
Efficiency and Convenience
When SEND became mandatory
From March 15, 2020, NDA and IND data should be submitted following SENDIG version 3.1.
- FDA announced its support for SEND v3.1
- Transition date
- NDA requirement date
- IND requirement date
SENDIG v3.0 and v3.1
| Version | Study types covered |
|---|---|
| SENDIG v3.0 | Single dose, repeated dose and carcinogenicity |
| SENDIG v3.1 | Single dose, repeated dose and carcinogenicity + Cardiovascular and respiratory (safety pharmacology) |
Single dose, repeated dose, carcinogenicity and safety pharmacology study results should be submitted in SEND format following SENDIG version 3.1.
More than dataset conversion
Dt&CRO provides not just dataset conversion but a full package for FDA approval with a CDISC instructor.
Submission package
Dt&CRO's LIMS and SEND compatibility
Other CRO data (Final Report)Dt&CRO LIMS programSEND Conversion Program → SEND data
Final Report- 01
Dt&CRO SEND conversion
We provide legacy dataset conversion of data provided by other testing facilities using our in-house SEND conversion program.
- 02
Dt&CRO LIMS synchronization
Datasets are automatically converted in accordance with existing raw data, using our own LIMS platform to maintain data consistency.
Dt&CRO is the first Korean organization to develop an in-house SEND program, signing a partnership agreement with the overseas corporation run by a co-author of the CDISC SEND standard. Our aim is to provide seamless, full-package technology services for domestic and foreign pharmaceutical and bio ventures for U.S. FDA registration and approval.