For all new drug applications (NDAs), abbreviated NDAs (ANDAs), and biologics license applications (BLAs), the US Food and Drug Administration (FDA) now requires clinical and nonclinical study data to be submitted electronically in CDISC format.
CDISC Study Data Tabulation Model (SDTM) and Standard Exchange for Non-clinical Data (SEND) are examples of these study data standards.
“Certara’s CDISC technology solution focuses specifically on streamlining CDISC SDTM and SEND PK data preparation, which is a complicated task,” Certara Senior Vice President Ellen Leinfuss told Outsourcing-Pharma.com.
“These standards support acquisition, exchange, submission, and archiving of study data,” she said, explaining that the requirement for INDs goes into effect later this year.
“Submissions that do not comply with CDISC requirements could potentially delay the regulatory review process,” added Leinfuss.
The new CDISC PK solution includes software, services, and consulting “for more effective knowledge transfer between databases and robust electronic submission protocols for sponsors and CROs,” she said.
The solution includes Phoenix CDISC Workflow Templates, Phoenix® CDISC Navigator, and Certara Strategic Consulting.