Early access programmes (EAPs) allow patients with serious or life-threatening conditions to receive investigational medicines outside of clinical trials when no satisfactory treatments are available. Although their primary purpose is treatment, EAPs are increasingly used to collect early real-world data to complement clinical development. Regulatory pathways for EAPs vary widely across countries, creating challenges for global submission documents or materials, which are further complicated when data collection is planned. Sponsors must navigate heterogeneous requirements for treatment protocols, ethics review, and contrasting expectations relating to data collection. Medical writers play a central cross-functional role in establishing EAPs, working closely with programme teams to develop treatment protocols, data collection plans, and informed consent materials that are clear, compliant, and tailored to each regulatory environment. Effective planning of these documents helps ensure timely access to investigational treatments and supports high-quality and harmonised data generation.