This is Barry, a drug created in the CARA Life Sciences PlatformTM. Let’s follow his end-to-end journey as a medicinal product through the Platform, from discovery to post-marketing, and see how connected processes in CARA make it easier to manage every stage of the product lifecycle.
Creation of the Active Substance in CARA
Creation and management of non-clinical Study Data
Creation, Authoring, Review and Approval of non-clinical Study Documents
Early data from Barry’s non-clinical trials begins to connect in CARA: Active Substances, non-clinical trial, docs created through CARA’s DMS functionality.
The first connections are formed: masterdata and core data are linked with the study documents and data from non-clinical processes.
With a successful non-clinical study, Barry is created as a pharmaceutical product in CARA. Time to plan the clinical study.
Creation of Clinical Study, Study Countries, Sites, and associated study parameters
Creation of Product Family. Attachment of data incl. Active Substances
Before proceeding with the clinical trial, we need to hand over to Regulatory to get authorisation from the authorities.
Traditionally you would move to a different, siloed system to complete this process, but with CARA Life Sciences, everything is connected in one platform.
In the CARA Life Sciences PlatformTM, everything takes place in one system, where all the data needed for the submission is stored.
Any correspondence from the authorities can be managed, tracked, and stored in CARA.
At this stage we connect to Safety. Any safety cases arising from the clinical trials and the related aggregate reports, as well as any complaints, are stored and managed in CARA.
The submission comes from together using all the data collected, and the documents authored throughout the process so far. Everything is easy to search, find, and use in the platform.
With Barry available on the market, some complaints may have been made and logged in CARA. These have been logged in Quality, and linked to Safety cases that have arisen.
Reported Complaints
Report adverse events and safety cases
Data collection and authoring of aggregate reports
These complaints and safety cases require us to create a quality event in CARA to update the information on Barry according to our internal workflows. From this, some variations like labelling changes and updated shelf life are spawned. Using the Quality Events as triggers, let’s manage these variations, submit, and track them all in CARA.
Using the same tools and processes as with marketing authorisation; submission management, applications, activities, events, submission authoring and review, it’s time to publish and submit to the authorities. You can track all of that outcome and validity back into the varied registration. And now those variations are also linked.
The data created during a product’s lifecycle comes from many different sources and requires contributions from many people. The aim of the CARA Life Sciences Platform (TM) is to take all of the parts of that process that can be simplified, and simplify them. Save time with automations, avoid duplicate work, and maintain consistency and compliance.
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