Genpro has developed intelligent submission tools that help sponsors to better prepare for their NDA/PMDA submissions
As Sponsor is preparing for their NDA submission, it is critical for them to verify the content and validity of the dataset folder per the FDA submission requirements. Datasets must meet the technical specifications per the Study Data TCG and eCTD validation criteria. Our submission validation framework will check whether the datasets that are provided for regulatory publishing is compliant. FDA Binding Guidance is already in effect. CDISC data standards is a mandatory requirement for every new drug submission. The Sponsor needs to be prepared for CDISC data submission which meets the minimum requirements set forth by the FDA and PMDA. Some of the features of the framework include..
Our framework will seamlessly integrate with SAS program checks which will be build against the FDA binding guidance document. This will be done using the SAS VIA REST Apis and hence will be able to use the SaaS architecture.
Pinnacle 21 is integrated to this framework in order to perform SDTM/ADAM compliance validation of the submission datasets. All errors/warnings will be identified and send to the submission group for correction and validation.
A set of standard ECTD publishing tools are also integrated into this framework so as to allow the sponsors to check for the Trial Management Folder. Thus the capabilities of the tool is extended beyond data submissions.
Dynamic Rule Engines are developed so that we will be able to check the sanctity of the M4/M5 folders for contents and structure. These checks will be used by the regulatory affairs, regulatory publishing, biometrics and quality control groups of the sponsor.