I am engaged, hands-on, evaluating and contributing to new solutions during development.
Now that FDA has issued the long awaited final guidance, knowing what to do, when and why is critical.
On December 18, 2014, the FDA 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.
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.