The RIM lifecycle of pharmaceutical products from early discovery, through development and trials to submission and post-submission tracking, updates, lifecycles and pharmacovigilance, is extremely complex. At the heart of managing the process is a combination of the Master Data on products and the documentation associated with every step of the process. Traditionally, managing these has involved implementing multiple silo systems with very little inter-system communication and thus data integrity.

The CARA RIM modules provides a pre-configured set of data objects to manage all RIM data.  At the heart is a set of Controlled Vocabularies (dosage forms, strengths, indications and so on) that are based on IDMP / SPOR.  The next layer is the company Product information, from product families down to Medicinal Products and Packaged products, as well as substance and studies management.  These two layers together capture the information required for IDMP / xEVMPD purposes, and can be further configured to individual customer needs, as well as acting as a Master Data Management system that other systems can query via REST API.

Finally, there are the Events, Activities, Applications and Registration objects, that are linked in a cascading fashion to each other, with automations during bulk creation of e.g. Activities from Events.

Every object has planned and actual dates and responsibilities data that can be used for planning and then for tracking through report dashboards.  They also have a unique ability to have supporting documents attached that are not intended for submission but use reference during the process.

All of this is support by the new Business Process Management capabilities of CARA that move simple document workflows to the next level.