Case
From EAP complexity to an execution-ready model
How InnoStrat helped a mid-sized pharma company establish a scalable Early Access Programme model and prepare for rollout across selected countries
The challenge
A mid-sized pharmaceutical company with limited Early Access Programme experience needed to establish a clear and scalable model for rollout across selected countries.
The client faced several challenges:
- No formal governance for high-stakes EAP decisions
- Limited internal EAP experience
- Ad hoc patient requests and unclear programme objectives
- Complex coordination across specialist vendors
Our approach
InnoStrat provided senior sponsor-side support across EAP strategy, governance and planning, bringing together the decisions needed to establish one coherent programme model.
Strategy & Framework
We established the strategic foundation for the programme:
- Global EAP Policy and SOP
- EAP plan, charter and ICF templates
- Kick-off scoping and risk assessment
Governance Setup
We created a clear structure for decision-making and oversight:
- EAP Review Committee
- Decision pathway from Core Team to Board
- Clear roles, oversight and escalation
Documentation & Execution Readiness
We developed the documentation needed to support execution and handover:
- Treatment plan and ICFs
- Safety/Data Management Plan
- SAE reporting forms
- Full documentation package for handover
The result
Leadership-aligned direction
The client established a shared strategic direction and rationale for key EAP decisions.
Reduced execution and compliance risk
Early clarification of scope, governance and responsibilities created a stronger foundation for execution.
Scalable programme model
A scalable, compliant global model was established and prepared for rollout in selected countries.
Protected patient continuity
The programme was prepared for a clean handover, helping protect continuity of treatment.
What this means for you
Managed Access Programmes bring together decisions that span functions, markets and specialist partners. Without clear ownership and governance, complexity can quickly become an execution risk.
InnoStrat helps sponsors connect strategy, governance and execution, providing senior sponsor-side support alongside internal teams and specialist vendors.
Our experience with EAPs is part of a broader Managed Access capability designed to help life-science companies move complex access programmes forward.
A note on terminology: We use Early Access Programmes (EAP) as an umbrella term for the routes by which patients access a medicine before or outside routine commercial supply. Depending on Country and pathway, these are also referred to as named-patient use, compassionate use (Article 83 and national schemes in Europe), expanded access (21 CFR 312 Subpart I in the US), pre-approval access, or managed access. Where we describe a specific regulatory pathway, we use that pathway’s formal name.
