caralogo

End to End solutions for Life Sciences

A SUITE OF SOLUTIONS TO COVER THE ENTIRE PRODUCT LIFECYCLE
– INCLUDING STRUCTURED AUTHORING (COMPONENT-BASED AUTHORING)

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.

 

Please see below for examples of how CARA can help.

Structured Authoring across all parts of your process

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.