FDA has issued final guidance for electronic submission of study data
Are you SENDReady™?
On December 18, 2014, the FDA has issued the long awaited final Guidance for Standardized Study Data for providing regulatory submissions in electronic format. The mandate essentially states that any studies starting 24 months after guidance is published must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog for NDA, ANDA, and certain BLA submissions.
Submit™ is a fully integrated nonclinical solution suite developed to support companies using
CDISC’s Standard for Exchange of Nonclinical Data (SEND).
The submit solution suite converts data from any source system into SEND files and allows
sponsors, CRO’s and regulators to share, visualize and analyze study data more efficiently.
- Enables efficient electronic exchange between sponsors, CROs & regulators
- Reduces manual processes & errors
- Adapts as your data collection systems evolve
- Creates SEND datasets in a few simple steps
- Technology value beyond regulatory submissions
- Creates SEND files from data management systems and files
- Translates to controlled terminology with no change to data collection
- Adds and edits data with audit trail
- Produces and converts XPT, XML and XLSX formats
- Manages SEND files received from CROs and Partners, and created from internal studies
- Checks against SEND guide and 'good data' rules
- Merges files to create a single comprehensive dataset
- Enables efficient SEND dataset review
Who is using Submit?
- Sponsors who outsource studies use submit to manage SEND datasets received from CROs. They
merge data that has been collected internally or received from other test sites into the SEND datasets.
- Sponsors with labs use submit to create SEND datasets for studies conducted in house.
- CROs are meeting the expectations of their sponsors for SEND with submit. Being ready to create SEND datasets ahead of the requirement adds value and efficiency to the services they provide.
Submit is available as a traditional on-site software solution or can be accessed via the Instem Cloud.
Instem also offers submit-services where clients upload their data to have it converted and returned as SEND datasets.
Submit™ is part of the Centrus™ solution suite