This paper outlines a combination of a Software as a Service on the cloud with Xbiom Workbench for Submissions and Studies, and an associated Managed Services concept that ensures streamlined support for Sponsors.
Sponsors including big and small pharma and biotechs are outsourcing their nonclinical studies to external CROs. The increasing use of SEND formatted data for these studies for FDA submissions mean that in addition to dealing with the planning and outsourcing of studies, sponsors must have a plan for managing the logistics of the SEND dataset supply chain. CROs can handle many of the parallel study designs with automation. However, SEND IGs are changing as new IGs are being released, and many of these will call for manual intervention to create SEND datasets that are good for submission.