Enabling pre-clinical data compliance for regulatory filings
Syngene’s SEND services team helps research organizations comply with the US food and drug administration (FDA) agency’s approval process for investigational new drugs (IND), new drug applications (NDA), and biological license applications (BLA). We compile data from our client’s non-clinical studies into a consistent digital format using the standard exchange for non-clinical data (SEND) format, an implementation of the study data tabulation model (SDTM) standard.
Capabilities
The SEND services team compiles SEND datasets for in-house executed in-vivo studies as well as for standalone in-vivo toxicology studies performed by other contract research organizations (CRO). We also convert studies done at other CROs, where data has been captured manually, into the SEND format. Since 2018, we have successfully delivered over 2 million data points and converted more than ten manually captured standalone study datasets into the SEND format.
Methodology
We convert all datasets using the latest versions of the SEND implementation guide (IG), i.e., version 3.0 or 3.1. We maintain high data integrity using the latest technologies, including Pristima® software and Pinnacle 21, to validate datasets against FDA-specific SEND validation rules and ensure SEND IG compliance. After conducting quality checks, we compare the datasets with the original study report, and document the differences in the non-clinical study data reviewer’s guide (nSDRG).
