Processes and systems

A CTMS (Clinical Trial Management System) is at the core of clinical IT landscape. It contains a wide array of master data about clinical studies and supports the organization performing the trial with tregard to managing all activities within the study.

Since the CTMS is involved in virtually all trial related processes, it also has a considerable number of interfaces. It contains the investigator and ethics committees address data which are e.g. required for sending out Dear Dr. Letters, it mirrors the site visit structure and trigger payments to investigators, etc.

When replacing a CTMS, it is thus inevitably important to invest an adequate amount of time and resources to analyze the business processes that the CTMS is supposed to support. The process analysis can then also be used to derive functional requirements for the URS.

Yesterday, I as at the kick-off for a new project, aiming at the revision of our CTMS, and it was clearly stated: First processes, then systems. Which reminds me of this:


©Far Side

I am very satisfied that this approach has become standard in our clinical development unit. Any new business project starts with a thorough process analysis and documentation. That's the way I like it!