"LORENZ was chosen as the first vendor to support the Regulatory Affairs Professional Society in their advanced training workshop," says Yaprak Eisinger, MD for LORENZ Life Sciences Group in North America. "LORENZ provided the entire solution, and all RAPS participants had to do was log on from their own notebooks via the RAPS wireless network. The technical infrastructure behind this setup is astounding in view of the fact that all participants were doing the exact same task at the exact same time during the workshop. Furthermore, it provided participants an opportunity to get a first glance at our newest software generation, LORENZ docuBridge® V."  

 

LORENZ further provided the trainers for the event, ensuring that all participants would be put into a position to be able to use the software appropriately. The trainers consisted of a mix of US as well as EU experts from LORENZ' Professional Services Group, as the task was to generate eCTDs for both the US and the EU.

 

"Upon learning that we were chosen to supply the eCTD building environment in February, we set up an immediate internal RAPS task force," says Kent Briggs, a Director of the Professional Services Group. "We drew in experts from our technical, training, testing and documentation teams.  We also included our development environment in the project, as we were about to use our newest incarnation, LORENZ docuBridge® V,  as our solution of choice."  

 

The eCTD training was completed successfully and the feedback has been positive. The event was the first such event for LORENZ docuBridge® V in North America and the system proved to master the tasks without any issues.

 

LORENZ will look to further broaden its investment into hosted solutions, already being the largest supplier of hosted Submission Management Solutions.  The new LORENZ docuBridge® V architecture further lends itself to optimise the technology setup in such environments.