01Medicines access
A considered route. A programme built to deliver.
Access strategy, programme design and post-trial planning, with the regulatory, supply and governance decisions brought together.
Explore medicines accessExpertise
Three connected capabilities.
One view of the programme.
IAE brings medicines access, evidence and regulatory governance together. The scope follows the decision you need to make and the work required to put it into practice.
Our three connected capabilities
02Evidence & research
A useful question. Evidence designed around it.
Evidence planning and research governance that connect scientific purpose, feasible collection and the people taking part.
Explore evidence & research03Regulatory governance
Clear responsibilities. Control through delivery.
Regulatory leadership, quality and GxP governance, provider oversight and supply transitions that make the agreed strategy workable.
Explore regulatory governanceThe connections are part of the work.
A supply change can alter regulatory responsibilities. An evidence plan can change the demands on an access programme. A provider’s scope can leave a critical interface uncovered.
IAE assesses these relationships in the context of the programme. Quality and GxP, safety interfaces, supply, data and provider oversight sit within that connected assessment. The assignment identifies what needs to change, who can decide and which specialist contributions are required.
Explore regulatory governance and deliveryPractical guides for
the next decision.
Compare the terms, clarify responsibilities and prepare the questions your team needs to resolve.
Post-trial access
Independent post-trial access planning for sponsors and delivery teams. Clarify commitments, route options, responsibilities and readiness before transition.
Plan the transitionVendor oversight
Independent vendor selection and oversight support for clinical, access and evidence programmes. Clarify scope, responsibilities, performance and transitions.
Clinical trial vendor selection, management and oversightEvidence planning
Integrated evidence planning and real-world evidence strategy: define the question, test feasibility and establish governance before commissioning research.
Define the evidence questionAccess terminology
Understand access terminology, why country context matters and who can answer. Independent guidance with official sources and clear next steps.
Compare the termsSupply transitions
Independent advice for clinical supply and medicines supply changes. Connect regulatory, quality, provider and continuity decisions before the handover.
Pharmaceutical supply chain consultingPatient and public involvement
Understand patient and public involvement, ask better questions about participation and explore research planning or community contributions with IAE.
Prepare for involvementEngage the expertise the decision needs.
A specific review, a defined workstream or continuing senior input. Each begins with an agreed scope and a useful output.
A focused decision review
A defined question, independent assessment and a recommendation with its reasoning, conditions and next actions.
A programme or workstream
Strategy, design or implementation with agreed outputs, responsibilities, timing and acceptance criteria.
Continuing senior leadership
Fractional regulatory leadership or reserved advisory capacity for recurring decisions, oversight and organisational change.
Your organisation. Your operating context.
The approach reflects your role, the relevant jurisdictions and the people who will carry the work forward. See all audiences and routes
Pharma & biotech
Senior input for leadership, medical affairs, clinical operations, regulatory and quality teams. Establish an access approach, commission useful evidence or strengthen oversight of the organisations delivering your programme.Explore your starting point
CROs, CDMOs & service providers
Build a credible service proposition and the operating arrangements behind it. IAE supports scope development, regulatory capability, sponsor interfaces, governance and implementation.Explore your starting point
Supply & logistics organisations
Understand how your activities fit the wider medicines pathway. Assess regulatory responsibilities, quality interfaces and the implications of country, provider or supply-model changes.Explore your starting point
Healthcare & pharmacy teams
Connect programme requirements with the realities of the receiving site. Clarify organisational responsibilities, feasibility and interfaces with sponsors and providers.Explore your starting point
Research teams & funders
Turn a research priority into a focused question, feasible plan and clear governance. IAE supports evidence planning and coordination of the appropriate specialist input.Explore your starting point
Charities & patient organisations
Bring community priorities into research, programme design and informed discussion. Discuss a defined advisory project or explore the separate community participation route.Explore your starting point
Patients, families and carers can find general information, signposting and participation boundaries in the community section.
Define the next piece of work.
Bring the programme, the decision or the concern. We will establish where IAE can contribute and what the assignment needs to deliver.
Discuss an assignmentScope, responsibilities and fees are agreed before work begins.