Resource Hub

Ontology-Driven Integration: IDMP Efforts with a FAIR Outcome
Generis and MAIN5 recently hosted a webinar “Ontology-driven Integration: IDMP Efforts with a FAIR Outcome.” The session featured key insights on the integration of IDMP with a focus on FAIR (Findable, Accessible, Interoperable, Reusable) data principles, showcasing how ontology-driven approaches can ensure effective data interoperability in regulatory frameworks. Michiel Stam,

Submission Documents on the CARA Life Sciences Platform
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 processes.

Submission Archive on the CARA Life Sciences Platform
Submission Archive on the CARA Life Sciences Platform completes the circle from authoring to submission to archive, giving you both a reference point or starting point to succeed in future submissions.

Safety Submissions & Distributions on the CARA Life Sciences Platform
The CARA Life Sciences Platform supports the ongoing task of distributing safety information on a periodic basis to affiliates, distributors, and other third parties responsible for safety reporting to NCAs and tracking interactions.

Generis Accelerates AI Adoption for Customers Across Regulated Industries
LONDON, July 29, 2024 — Generis, creator of the cloud data, content and business process management platform CARA™ announced the addition of cutting-edge Artificial Intelligence (AI) technologies to CARA in order to empower their customers to harness next-gen capabilities to improve and streamline their processes. This move is supported by

Promotional Materials on the CARA Life Sciences Platform
CARA provides comprehensive support for both image and video formats, enabling users to collaboratively review materials, share them with colleagues, and publish content seamlessly within the platform.

Complaints Management on the CARA Life Sciences Platform
Managing complaints is not just a regulatory requirement but impacts the public image of your company. The CARA Life Sciences Platform allows you to ensure that complaints are quickly and automatically routed on workflows and escalations through to the resolution.

Learning Management System on the CARA Life Sciences Platform
Training and certifying employees in the same system as the documents themselves ensures a seamless experience with greater oversight. The CARA Life Sciences Platform provides the ability to define courses, roles and curricula for such content, but also to log – and generate training certificates for – any external training,

Risk Management on the CARA Life Sciences Platform
The CARA Life Sciences Platform offers a unified and traceable way to create and distribute Risk Management Plans and associated documents to Affiliates and Distributors. Traditionally, this process would involve multiple external systems – one for sharing content and another for registering and reporting on implementation status. With the CARA
