lsafety

Integrated Safety

Predict, analyse, and react faster with a seamless platform for safety data.

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  • PV Case Management
  • PV System Master File (PSMF)
  • Safety Submissions and Distributions
  • Risk Management
  • Medical Inquiries
  • MedDRA Integration
  • Safety Data Exchange Agreements (SDEAs)

Connectivity

Leverage a centralised system for all your global processes with a cloud-first solution.

Visibility

Gain true oversight with easy reporting, dashboards, and a ‘where-used’ system.

Consistency

Take control of all your information with best practices across the board to reduce re-work and time wasted.

Proactivity

Automate work for your colleagues with collaboration and AI, ready for the challenges of tomorrow.

PV Case Management

PV cases can be created in CARA from a number of input sources (XML input, emails, manual entry), and then processed to closure, including submission to the NCA using the ICH E2B R2/R3 standard.

PV System Master File (PSMF)

Managing the PSMF is a complex ongoing task, between updating sections owned by different parts of the business, and the challenge of creating the Annexes from information that comes from a variety of sources…

Safety Submissions and Distributions

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.

Risk Management

Risk Management Plans and associated documents need to be created and distributed to Affiliates and Distributors. Traditionally those tools involve external systems for sharing content and a separate system for registering and reporting on implementation status…

Medical Inquiries

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

MedDRA Integration

Ensure the data in your CARA Life Science Platform meets the standards and norms of the MedDRA dictionary / thesaurus.


Safety Data Exchange Agreements

Rather than being a requirement that can be met by a stand-alone contracts management system, this requirement is more complex. CARA allows for the interaction of these contracts with the Pharmacovigilance domain, ensuring consistency and accuracy of data, and reducing manual input and tracking.

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