Certara, the leading provider of decision support technology and consulting services for optimising drug development and improving health outcomes, has announced the launch of a new solution for preparing, analysing and submitting PK data in Clinical Data Exchange Standards Consortium (CDISC) format.
CDISC supports the acquisition, exchange, submission and archiving of non-clinical and clinical data.
“As the leader in PK modelling, Certara is committed to providing its clients with technology solutions that streamline both the drug development and the regulatory submittal processes,” said David Munro, President of Certara’s software division.
“To that end, we have developed these new tools and services to remove the time-consuming task of converting data to CDISC format manually. Manual efforts are both time-consuming and more error prone, which can slow the drug approval process.”
The US Food and Drug Administration (FDA) now requires that clinical and non-clinical study data for all new drug applications (NDAs), abbreviated NDAs (ANDAs) and biologics license applications (BLAs) be submitted electronically in CDISC format. On 17 December 2017, that requirement will extend to all investigational new drug applications (INDs).
In 2016, there were 160 NDAs and BLAs, 864 ANDAs, and 786 INDs submitted to FDA.
Aside from FDA, Japan’s Pharmaceuticals and Medical Devices Agency has also adopted the CDISC standard for clinical data. In addition, the European Medicines Agency, Korea Ministry of Food and Drug Safety, and the China Food and Drug Administration are considering using CDISC standards.
Certara’s CDISC PK solution includes software, services and consulting:
- Phoenix CDISC Navigator provides a user-friendly interface that seamlessly imports CDISC data into Phoenix, converts CDISC data into an analysis-ready format, and then exports CDISC formatted PK parameters. It is ideal for current users who perform PK non-compartmental analysis (NCA) in Phoenix WinNonlin
- Phoenix CDISC Workflow Templates are available for Phoenix users who require automated preparation of NCA Standard Data Tabulation Model (SDTM) clinical and Standard Exchange of Non-Clinical Data (SEND) non-clinical data sets in CDISC-ready formats.
- Certara Strategic Consulting is the largest provider of expert PK and PK/pharmacodynamic modelling services and can provide datasets in CDISC-compliant format.