The tender was designed to accommodate a maximum of 400 users onsite as well as up to 100 users accessing the system externally.

“We are very happy to have won this tender,” said Wolfgang Witzel, president of LORENZ Life Sciences Group. “We are steadily growing our agency business and are getting very valuable feedback from agency users as to the required functionality. Adding the Polish agency to our list of customers means that more focus can be put on the agency requirements. We welcome this opportunity to work with the Polish agency.”

LORENZ currently supplies eCTD review systems to five agencies around the world, four of whom are in Europe. LORENZ currently foresees a growing trend as the move is away from tool-based approaches to a more holistic business process approach. The LORENZ docuBridge system, which is at the heart of the tender, is able to comply with any type of procedure in the EU (centralized, decentralized, MRP, national), US, Canada and Japan. Further, its configurable export and import modules allow the system to be used in a variety of procedures that are not part of the ICH or EU/North American/Japanese submission architectures.

LORENZ is also the only vendor to ensure just one code-set is used to develop both the industry as well as the agency solution: both are based on the same framework, which significantly reduces support issues and ensures rapid updates to changing regulatory requirements.

The news arrived during the annual LORENZ user conference, userBridge 2009, which hosted 130 delegates from 19 countries. The user conference, by coincidence, was held in Warsaw, Poland and added to the overall very enjoyable and informative event.