Expanded and managed access programmes

Cisiv offers a validated integrated end-to-end platform, which can be set up per programme, or as an enterprise tool for pharmaceutical manufacturers who want to own and manage requests and data.

Benefits of the platform:
  • An integrated tool for managing early access requests, through workflows
  • Streamlined processes
  • Facilitation of direct engagement with relevant stakeholders
  • Quality compliance with FDA and EMA requirements
  • A fully industrialised platform, that is also flexible
  • A customised right-sized e-solution

Expanded access programmes are legislative frameworks, used by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to enable the therapeutic use of an unauthorised intervention (or of an authorised drug for an unauthorised indication) for patients with a life-threatening disease, outside of a clinical trial.

This can also be referred to as managed access, early access, early access to medicine schemes or compassionate use programmes.
One of the main challenges of managed access programmes is to streamline the communication between all the stakeholders (patients, physicians, pharmaceutical manufacturers, regulators and vendors).
Cisiv offers a single platform that enables:
  • Workflows for submission and approval: a series of workflows are generally required for a healthcare practitioner to request an unlicensed drug. This is often reviewed per patient or for a cohort.
  • Data collection: Cisiv’s platform allows for the collection of adverse events and the longitudinal collection of treatment information as well as re-order for the investigational medicine.
Learn more about how to get started with real world data by listening to our webinar here.
To learn more about expanded and managed access programmes and our technology, get in touch.

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