|
The development of Promasys (Protocol Management System) started in 1988, 2 years after the establishment of the Centre for Human Drug Research (CHDR), a state of the art clinical research institute in Leiden, the Netherlands.
In that year, Adam Cohen, professor of Clinical Pharmacology and CEO of CHDR and Jos Hennen, biologist and IT systems specialist, laid down the concept of a software system that helps a clinical research organization to work efficiently, to produce high quality clinical trial data, and to be compliant with regulations. From the beginning, it was a key requirement that users should be able to do everything, including setting up new studies and making CRF's, without having to do any programming. This has since been a central thread in the development of Promasys.
Promasys as it stands today is the result of eighteen years of experience and in-the-field usage in the daily practice of clinical trials. It has a track record of successful use in more then 300 trials, both industry sponsored trials and investigator initiated studies. Continuous input from users, researchers, study nurses on the workfloor, QA staff, data entry personnel, but also from people involved in regulatory decision making, helped to make Promasys into a quality system for data management and workflow support. Clinical trials conducted with Promasys have resulted in at least 250 scientific papers in the international scientific literature.
In 2004, the independent company Promasys BV was established to take care of the further development and marketing of the software.
|