Strategic Pre-Approval Access Planning
Access to essential unlicensed medicines when no other options are available can save or transform lives. These services are one of the most valuable that Medical Affairs provides.
About This Service
Pre-approval access may be referred to by other names such as expanded access programs, compassionate-use programmes, named patient use, early access to medicines etc.
Pre-approval access enables vital use of unlicensed medicinal products for diseases where there are few/no treatment options and where patients suffer from serious or life threatening conditions.
Patients in these programmes then transfer onto commercial supply as soon as the drug is commercially available/according to regulatory requirements.
Circuit Medical can support your organisation with these programmes.
Where We Can Support You
Develop strategic ambition and guardrails to manage programme risks
Develop eligibility criteria
Help build your pre-approval access forecast and support supply and distribution planning.
Develop/Evaluate the bioethical rationale for pre-approval access.
Plan to include post-approval risk mitigation proposals.
Build an evidence generation plan through data collected via a pre-approval access programme.
Define and collect metrics to support analysis and evaluations of your programmes.
Pre-Approval Access brings Medical Affairs closer to patients and care givers
Modern pre-approval access programmes that encompass innovation, robust bioethical foundations and data generation methods can bring patients many benefits quickly and directly.
Why Choose Circuit Medical
We are relentless in our pursuit to help take your Medical Affairs delivery to a new level. Click on Circuit Medical Consulting to find out how.
