United States
Make the next program decision with a clearer view of feasibility, responsibilities and delivery. IAE brings independent medicines-access, evidence-planning and regulatory-governance advice to pharmaceutical and biotechnology teams working on U.S. programs.
Clarify the proposed pathway, sponsor and treating-team responsibilities, documentation needs and operational handoffs before committing to an expanded access program. A focused review can provide a program-scope brief, responsibility map and prioritized readiness actions.
Explore medicines-access supportStart with the question the evidence needs to answer. Define the purpose, feasible data sources and governance before adding data collection to an access program. The output is a practical evidence-planning brief, not an assumption that treatment access is a clinical trial.
Explore evidence and research supportIdentify decisions, owners and acceptance points across regulatory, clinical, supply and service-provider interfaces. Support can be scoped around a readiness review, provider transition or post-trial continuity plan.
Explore regulatory-governance supportShare the decision, program stage and timing. We agree the bounded output and responsibilities before commissioned work starts.
Discuss your U.S. programPlease do not include patient details, medical records or confidential documents. Individual treatment requests belong with the responsible clinical team or official program. Information and official routes.