Enabling preclinical 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 nonclinical studies into a consistent digital format using the standard exchange for nonclinical data (SEND) format, an implementation of the study data tabulation model (SDTM) standard for nonclinical studies.
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.
Capabilities
Our SEND services include the following:
- In-house executed in vivostudies
- Standalone in vivo toxicology studies performed by other contract research organizations (CRO)
- Conversion of manually captured data from other CROs into SEND format
Data integrity
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).
