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CARA Life Sciences Regulatory Logo copy.

Submission Documents

Modern Content Management

Submission Documents

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Managing submission documents on the CARA Life Sciences Platform™ is based on the DIA Reference Model, including all document artifacts and metadata, with some adjustments based on industry best practices.
 
Create a Global Dossier and then regional derived dossiers, with re-use of content to ensure maximum efficiency of process.
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The CARA RIM and IDMP modules extend the functionality to cover the submission planning, regulatory events, applications and registrations. Publish through one of our partners.

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Trusted to lead

The majority of the largest global life sciences organisations use CARA for submission content management. In fact, CARA has been providing the most powerful CMS since 2001. Recently, submissions for the world's most common vaccines for COVID-19 were authored in CARA.

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Benefits

Maximise the User Experience

A modern interface makes the CARA Life Sciences Platform easy to use and personalised to the user's work

Access and Manage Content in One Place

A single content management platform simplifies workflows and collaboration

Meet Corporate and Regulatory Standards

Built for industry best practice, but flexible enough to suit your business

Total Lifecycle

From creation to access, search, review, approval, publication and archival

Automate Manual Processes

Powerful and flexible workflows bring digitise business process across the organisation

Find Everything Instantly

With filters, folders, reports, dashboards and a 'google-fast' search engine, users can find their work instantly

Securely Share Content with Partners

Better security models and time-limited, secure access mean you can work seamlessly with affiliates and other partners

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Features

• Document classification and metadata based on the DIA Reference Model

• Creation of content based on templates

• Collaborative authoring – multiple users simultaneously

• Review and approval of content including eSignature

• Create submission structure in CARA and assign content

• Drag and drop CARA structures or individual documents to publishing tools

• Build submission structures automatically from submission planning tools in CARA

• Archive submissions from publishing tools to CARA, including automatic traceability to the source components used for publishing

• View submissions from CARA using partner tools such as Dossplorer

• Manage Master Data in CARA IDMP module, or pull in from external tools to use on document metadata

Learn more about IDMP & Product Management 

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Learn more about RIM

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RIM

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