Resource Hub

Whitepaper

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,

Read More
Datasheet

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.  

Read More
Press Release

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

Read More
Datasheet

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.  

Read More
Datasheet

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,

Read More
Datasheet

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

Read More

Contact