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for Regulatory Information Management (RIM)

Do you need to know:

What is approved, and where, globally?
What your affiliates have done locally?
The plans and status of all ongoing regulatory work?
CARA provides this in a few easy clicks

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.

CARA provides the optimal solution to the situation – allowing companies to have a single UI for RIM that simplifies the business users’ experience, with the RIM data seamlessly connected to submission assemblies and individual documents, allowing full traceability, impact analysis and an easy Current Approved View of your products globally.

How does it work?

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.

CARA RIM COMPONENTS

Submission Forecasting / Planning

Dossier (Assembly) Management

Document Management

Applications, Events and Activities

Product Registration

Commitment Management

Health Authority Interactions (Q&A, correspondence)

Regulatory Archive of published submissions

Labelling (CCDS to labels, translations and artwork)

Reporting and Analytics / Integrated Regulatory Information

Data Management and Information Standards

Design History File – Medical Device

Regulatory Intelligence (2021)

Safety Reporting / submissions

Dossier publishing with our publishing partners

See our main LIFE SCIENCE SOLUTIONS page for details of each of the modules.

End to End RIM with CARA

Over 470,000 users and growing…

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