Independent medicines access, evidence and regulatory advice

Complex science.
Clear direction.

Decisions about medicines access rarely sit with one team. IAE helps sponsors, providers and research commissioners assess the options, clarify responsibilities and turn a defined decision into a practical plan.

Led by Daniel McCormickFounder & Principal

What brings you here?

Move a piece of work forward.

An organisational challenge, a research question or a service to develop. Find the contribution IAE can make.

Find support for your work

Bring your perspective.

Help shape a conversation, highlight a recurring barrier or explore a community contribution.

Explore ways to contribute

See how the decisions connect.

The most consequential gaps often sit between well-defined pieces of work.

A route can be plausible while the handover is unresolved. Data can be available while the evidence question is unclear. IAE makes those connections visible, assesses the options and turns the agreed direction into work that sponsors, providers, researchers and healthcare teams can use.

Three connected capabilities.

The right depth of support, organised around the programme and the decision in front of you.

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 access
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 & research
03Regulatory 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 governance

What would change your decision?

The IAE Decision Room explores three fictional industry situations. Change an assumption, inspect the reasoning and see how the proposed next step changes. Each example includes a worked decision brief and an illustrative output, available without registration.

Original fictional industry scenarios. They illustrate decisions, not client assignments or delivered outcomes.

One programme, different expectations

One team plans for existing study participants; another expects new requests. The provider has priced a narrower scope. Which programme should the organisation assess?

Explore the programme decision

A dataset looking for a question

A collection plan could describe people’s experience or try to compare outcomes. Which question does the evidence need to answer, and what would change in the design?

Explore the evidence decision

Ready to hand over; ready to receive?

The pack is prepared and people are available. What must be agreed and evidenced before the receiving organisation can accept the responsibilities?

Explore the provider decision

Read “A good plan needs a shared understanding” in Access in the Open.

Experienced judgement. Personally delivered.

I help organisations make complex decisions about medicines access and evidence, then put those decisions into practice.

Daniel brings senior regulatory leadership together with a background in clinical academic research. His experience connects international access programmes, post-trial transitions, real-world evidence planning and regulatory governance.

IAE’s advice is independent of a medicine supply or logistics sale. The scope is shaped around your programme.

Meet Daniel and the approach

Better understanding. More voices.

Patients’ and families’ perspectives should help shape the work. Bring a recurring question, an experience that deserves attention or an idea for shared learning. There is a place to contribute without becoming a client.

Explore community participation

General information and signposting. Treatment-access requests remain with the official company or programme channels.

Make the next decision with clarity.

Tell Daniel what you are planning, what has changed or the decision you need to make. A short outline is enough to start.

Speak with Daniel

Scope, responsibilities and fees are agreed before work begins.