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End to End solutions for Life Sciences

A suite of solutions to meet different user experiences
– whatever your field of expertise

Senior leaders from across the AstraZeneca business were genuinely taken by surprise by the extent of the positive reaction to Cara … they had never before seen such a turnaround in user sentiment from a system improvement initiative, nor one accomplished so seamlessly and smoothly

ASHLEY BIRCH Global Head, Information Strategy Systems and Analytics, AstraZeneca

CARA is a fast, user-friendly and highly personalisable user interface for content management systems, making it simple for users to create, access, search, review, approve and publish information. Generis has brought together a range of CARA solutions to offer different user experiences across various specialised fields.

Life science companies, including pharmaceutical, biotech and medical devices, operate in a highly regulated environment. The nature of the business means every department is both data and document-intensive and companies are tasked with maintaining tight regulatory compliance such as the FDA’s 21 CFR Part 11 and the EMA’s Policy 70.

Generis solutions for the Life Sciences industry support critical processes where compliant management of all content and documents is essential whilst supporting collaboration across the enterprise and with external partners and contractors.

CARA is the user interface of choice for over thirty Life Science companies, including 8 out of the top 10. For those who have moved from  Documentum’s Webtop, the improvement experienced in productivity, satisfaction, performance and reliability is significant.

With several life science-specific modules available adding specialist functionality, CARA has a suite of solutions to suit all fields of expertise. In addition, the platform is underpinned by a business rules configuration layer which allows rapid setup and configuration of the repository to the organization’s precise requirements.

CARA’s key features include:

Personalization
users in CARA can choose the way CARA looks and works for them
Flexible Navigation
Users and admins can build their own navigation tree for both simple and complex queries
Searching
With seven different ways to search, CARA provides quick ways for users to get their information
One-click display of information
CARA widgets show all you need to know about a document
Different views for different users
Define different views for different user groups or usage scenarios, allowing users to work in the way that best supports their processes.

Simplified User Experiences
Different experiences designed for different users, whether occasional or heavy users, external partners or remote access
Comprehensive Dashboards and Reports
report on any metadata and show the results as tables, charts or graphs, with easy export to Excel
Extend core features
CARA provides access to all the core features of the underlying system, while offering extensions and improvements to many
Fully Configurable AND Customisable
allowing the setup of different use cases, for fast deployment and easy validation
Rich REST web services layer
Easily integrate third party applications

Please see below for examples of how CARA can help.

R&D / Regulatory Submissions / eCTD

R&D / Regulatory Submissions / eCTD

Standard data structure and metadata based on the DIA Reference Model for handling submission documents of all kinds including publishing and eCTD viewing.

GxP / SOP / Quality

GxP / SOP / Quality

Standard data structure and metadata based on the DIA Reference Model for SOPs and other Quality documents including controlled printing, full lifecycle and workflows and a viewing portal.

eTMF

eTMF

Standard data structure based on the DIA Reference Model for Electronic Trial Master File documents, including new site handling, reporting (missing documents etc.) and integration with multiple CTMS systems and an Investigator Portal.

Labelling

Labelling

Full label lifecycle from Core Data Sheet through translations to branch versioning per country and Health Authority approval management. Structured content authoring and print shop portal.

Pharmacovigilance

Pharmacovigilance

Integrate seamlessly with ARGUS or ARISg for case management with content securely stored and versioned in CARA.

Safety Data Exchange Agreements

Safety Data Exchange Agreements

Store and track Safety Data Exchange Agreements (SDEA) with contract expiration workflows and automatic single button generation of PSMF Annexes for submissions.

Medical Information

Medical Information

Deal with incoming Medical Information requests via call centers, emails and more. Real time searching for answers, including automatic sending, and full per-country data privacy handling.

LIMS

LIMS

Document handling optimised for clean-room conditions on mobile devices, including QR code usage and easy form filling to generate dynamic PDFs.

Medical Devices

Medical Devices

DIA Reference Model-based data structure and management of Design History Files (DHF), Device Master Records (DMR) and Device History Records (DHR).

Sales & marketing

Sales & marketing

Leverage submitted labelling and manage the associated sales and marketing documentation, including videos (with built in preview and annotation) and artwork.

Corporate (IT, Legal, HR)

Corporate (IT, Legal, HR)

Full set of standard templates and data structure for IT project documentation, contract / legal functionality such as document comparison and review / portal sharing, and Human Resources files.

IDMP

IDMP

Data management through CARA integrated with your content management to provide IDMP functionality integrated with other solutions in the RIM space.

Regulatory Correspondence

Regulatory Correspondence

Automate capture of incoming correspondence via the CARA Staging area, including email attachment extraction. Link to Dossiers and prepare and relate answers and commitments.

Submission Planning & Tracking

Submission Planning & Tracking

Build dossiers from planning sheets, Excel export lists or third party tools, and then track the progress, including metrics from one submission to the next for process improvement.

PSURs / Educational Materials

PSURs / Educational Materials

Manage the dissemination of PSURs to affiliates and partners, along with Educational Materials, and track the progress of reporting to local agencies.

RIM

RIM

Combine one or more of the CARA solutions, and/or integrate with existing tools to make CARA the RIM portal for your enterprise.

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