CARA Life Sciences Platform

The CARA Life Sciences Platform is an AI-powered, unified data and content management platform designed for regulated life sciences industries. Built by Generis, it brings together Regulatory Affairs, Quality, Safety, and Clinical teams in a single environment, enabling organisations to bring life-saving treatments to market faster while maintaining compliance and operational control.

Rather than offering disconnected point solutions, CARA provides a true platform architecture where data and content flow seamlessly between all modules without the need for separate integrations. A common user interface across all business processes reduces training overhead and improves adoption, while a single licence grants users access to every solution on the platform.

Regulatory Affairs Capabilities

• Regulatory Information Management (RIM) to simplify, standardise, and automate regulatory processes
• Submission Archive and Submission Documents management
• Promotional Materials review and approval
• Medical Device Submissions handling
• Labelling management
• SPOR Subscription integration

Quality Management Capabilities

• Quality Management System (QMS) to gain control of global quality processes and drive compliance
• Quality Documents Management for centralised content control
• Audit and Inspection Management
• Batch Records Management
• Learning Management System (LMS) for training and competency tracking
• Quality Innovations to support continuous improvement

Integrated Safety Capabilities

• Pharmacovigilance (PV) Case Management for end-to-end adverse event handling
• PV System Master File (PSMF) management
• Safety Submissions and Distributions
• Risk Management workflows
• Medical Inquiries handling
• MedDRA Integration for standardised medical terminology
• Safety Data Exchange Agreements (SDEA) management

Clinical Operations Capabilities

• Clinical Trial Management System (CTMS) for end-to-end trial oversight
• Electronic Trial Master File (eTMF) for digital document management
• Medical Writing support to improve interoperability and communication

Core Platform Features

• Powerful process automation supporting security, versioning, workflows, lifecycles, tools, and integrations tailored to each use case
• True platform architecture enabling seamless collaboration, discovery, and traceability across all business areas without additional integration effort
• One User, One Licence model allowing individuals working across multiple business functions to access all use cases under a single account
• Common interface across all modules to reduce training requirements and accelerate user adoption

Measured Efficiency Gains

• 155% improvement in Regulatory Submissions efficiency
• 321% improvement in Labelling processes
• 270% improvement in PSUR and Safety Distributions
• 450% improvement in PSMF management
• 390% improvement in Medical Inquiries handling

Future-Ready and Flexible Architecture

• Designed to provide foundational capability for continuous innovation rather than short-lived point solutions
• Low-code rapid application building enables life sciences companies to adapt, pivot, and implement new solutions as business needs evolve
• Delivers both industry-standard best-of-breed applications and the ability to digitally transform processes unique to each organisation

CARA is deployed globally, with Generis offices located in Sarasota FL, London, Amsterdam, Frankfurt, and Tokyo. The platform is built with AI traceability and auditability at its core, addressing the regulatory imperative for security, privacy, and source visibility in AI-assisted workflows — making it suitable for highly regulated life sciences environments.