Managed Access Programmes
One strategy. One operating model. One clear path to execution.
Managed Access Programmes bring together complex strategic, regulatory, operational and cross-functional decisions. InnoStrat helps life-science companies turn these decisions into a clear, coordinated and execution-ready programme.
We support sponsors across the programme lifecycle, from defining scope and governance to establishing the operating model, coordinating specialist vendors and preparing for execution.
Our experience includes Early Access Programmes and other managed access pathways across markets.
The critical risks in Managed Access Programmes often sit between functions. Clear ownership, governance and cross-functional alignment are therefore essential.
01 | Scope & Governance
Which programme scope and ownership do we need?
We help define the business case, objectives, strategic and risk position, priorities and governance framework.
Key deliverables:
- Business case and strategic assessment
- Programme scope and objectives
- Governance framework
- Roles, responsibilities and decision rights
- Risk and resource considerations
02 | Operating Model
Which operating model will enable effective execution?
We help establish the operating model, define workflows and coordinate the specialist partners needed to make the programme work across functions and markets.
Key deliverables:
- Operating model and workflows
- Specialist vendor selection and liaison
- Start-up documentation
- Training and tools
- Cross-functional coordination
03 | Execution Plan
What are our critical data needs and how will the programme evolve or end?
We help translate strategy into a practical execution plan with clear oversight, communication, patient criteria, data decisions and transition planning.
Key deliverables:
- Strategic data and evidence decisions
- Programme oversight and communication planning
- Inclusion and exclusion criteria
- Patient continuity planning
- Exit and transition strategy
One integrated MAP plan
Scope & Governance → Operating Model → Execution Plan
Our approach connects the decisions that need to work together, creating:
- Clear scope and ownership
- Alignment across internal functions
- Consistency across specialist vendors
- A practical path from strategy to execution
- A scalable programme model
Early Access Programmes: Turning access strategy into execution
Early Access Programmes are one important application of Managed Access expertise. They bring together Medical, Regulatory, Supply, Legal, Quality, Pharmacovigilance and specialist vendors, often across multiple markets.
InnoStrat helps sponsors establish the strategic direction, governance and operating model needed to move an EAP forward.
Our support can include:
- EAP strategy, scope and governance
- Operating model and specialist vendor coordination
- Programme documentation and workflows
- Strategic data and evidence planning
- Patient inclusion, continuity and exit criteria
- Sponsor-side oversight and decision support
Working with your specialist vendors
Managed Access Programmes often require multiple specialist partners across supply, logistics, pharmacovigilance, data and programme operations.
InnoStrat works alongside these vendors to establish strategic direction, clarify decision rights and facilitate alignment across the programme.
The goal is a connected operating model where internal teams and specialist partners understand what needs to happen, who owns it and how decisions are made.
Why work with InnoStrat?
Senior Managed Access capability: Our consultants bring hands-on experience from inside the life-science industry, combined with an independent outside view.
Sponsor-side ownership: We connect decisions across internal functions and specialist vendors, helping maintain momentum from strategy through execution.
An independent view: We challenge assumptions, pressure-test governance and vendor solutions, and help identify blind spots early.
Capability that stays with your team: We establish structures, processes and documentation that strengthen your organisation beyond the immediate programme.
What can a well-designed Managed Access Programme create?
Managed Access Programmes are ultimately about enabling appropriate patient access. Depending on the programme and its design, they can also create value across patients, healthcare systems and the wider product lifecycle.
Patient value
- Appropriate access to treatment
- Continuity of care
- Broader treatment experience
Healthcare value
- Treating-centre experience
- Stronger healthcare networks
- Supply and process readiness
Evidence and lifecycle value
- Real-world data and insights where appropriate
- Complementary evidence generation
- Input to evidence planning and launch readiness
The appropriate level of data collection depends on the programme. InnoStrat can help assess where RWD adds value and incorporate it into a compliant programme design.
Ready to discuss your Managed Access Programme?
Whether you are defining programme strategy and governance, establishing the operating model, selecting specialist vendors or preparing for execution, InnoStrat provides senior sponsor-side support across the Managed Access lifecycle.
Book a complimentary 30-minute MAP readiness consultation: info@innostrat.net.
