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Syngene’s SEND Services:


Enabling pre-clinical data compliance for regulatory filings

Standard Exchange for Non-Clinical data (SEND) is an implementation of the SDTM standard for non-clinical studies that specifies the way in which to collect and present non-clinical data in a consistent digital format. SEND compliance is mandatory for submission of data for IND (investigational new drug), NDA (new drug application) and Biological License Applications (BLA) for FDA approval.

Syngene can assist research organizations in compiling SEND datasets for in-house generated in vivo studies as well as standalone SEND data services for in vivo studies performed by other CROs.

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Syngene International Ltd. Biocon Park, SEZ, Bommasandra Industrial Area - Phase - IV, Bengaluru 560099 India.

To discuss how Syngene can fulfil your SEND-related requirements, information on our rapid turn-around times or pricing, please fill in the virtual meeting request form.

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Why Syngene for SEND services
 

• Successfully delivered more than 2 Million data points
• Provide SEND datasets for in vivo studies executed inhouse as well as standalone SEND data services for in vivo Tox studies performed at other CROs
• Capability to convert Studies performed at other CROs where data has been captured manually into SEND format. Completed more than 10 such standalone SEND studies since 2018
• Use latest technology including Pristima® software and Pinnacle 21 to ensure high data integrity
• Convert data sets to the latest version of SEND - IG 3.0 or 3.1 
• Data validated against FDA-specific SEND validation rules using Pinnacle 21 Validator to ensure SEND IG compliance
• QC checked dataset verified with study report and any difference documented in non-clinical Study Data Reviewer's Guide (nSDRG)