Expanded Access Programs

Early access programme services

EAPs can shorten timelines and create a strong foundation for European success

Expanding into Europe comes with unique challenges – diverse regulations, cultural nuances and significant risks. Before full regulatory approval or whilst awaiting local reimbursement decisions, companies need pathways that accelerate medicines to patients whilst gathering evidence to maximise commercial success and demonstrate value to regulators and payers.

Sciensus’ regulatory, distribution and patient engagement expertise enables faster, compliant market access through early access programmes. EAPs provide real-world evidence that strengthens HTA submissions and builds trust before pricing discussions, whilst allowing companies to validate operational readiness and execute a flawless European launch in a controlled setting.

Expanding access without adding complexity

Faster patient access to treatments

Physicians and patients can access unlicensed therapies for serious or life-threatening conditions, addressing urgent unmet medical needs.

Real-world evidence to support regulatory and payer decisions

EAP data complements registration trials, helping regulators and payers evaluate treatment value and supporting future pricing and reimbursement discussions.

Smarter launch planning and commercial advantage

Manufacturers gain actionable insights from RWE, improve operational preparedness for launch and use EAP experience to strengthen value propositions with authorities.

Faster access to patients in Europe

The drug development process is long and fragmented, unique European healthcare and regulatory systems can add even more time to the process. Sciensus can accelerate your access to patients through a turn-key EAP program. Leveraging over 30 years of experience across Europe, Sciensus can identify the right patients, deliver drug and engage patients in their care, ensuring that your therapy is accelerated to patients who need it and that you can gather the critical insights needed to fuel your full commercialisation process.

End-to-end expertise for programme success

  • Regulatory expertise and market access

    Confidently navigate complex, country-specific regulations with tailored guidance on approvals, programme types, compliance requirements and data collection.
  • End-to-end programme delivery

    From regulatory submissions to patient enrolment, supply chain logistics and safety monitoring – we manage every step to ensure seamless and compliant programme execution.
  • Patient access and evidence generation

    Enable faster access to life-changing treatments while capturing valuable real-world insights to inform regulatory submissions, market access strategies and future commercialisation.

    Ready to expand access without regulatory headaches?

    Get in touch to discover how our local expertise and pan-European infrastructure handle the complexity, so you can focus on patients

    Expanded access programme vs. clinical trials

    Clinical trials for rare disease therapies, as well as more prevalent speciality care illnesses can be infrequent and challenging for several practical and ethical reasons. Early access programmes can be an attractive alternative for companies who wish to widen potentially lifesaving access for patients who are not eligible for a clinical trial.

    Unlike clinical trials, early access programmes: Do not have strict eligibility criteria, making access easier for a broader population. Allow patients to live their daily lives while receiving treatment. Still involve monitoring for safety and efficacy but in a real-world setting

    Why partner with Sciensus?

    Demonstrated success in unlocking Europe

    30+ years of experience delivering successful EAPs across 70+ therapy areas.

    Established European relationships

    Leverageable network of over 4,000 wholesalers, hospitals, pharmacies and clinics

    Global reach, local expertise

    Seamless delivery across borders with in-depth knowledge of local regulations.

    Frequently asked questions

    What is a patient support programme (PSP)?

    A PSP provides resources, tools and services that go beyond medication, including adherence support, education, emotional wellbeing and access to care.

    How do PSPs improve adherence and outcomes?

    By combining digital tools with human support, PSPs help patients understand their treatment, manage side effects and remain engaged throughout their therapy.

    What therapeutic areas does Sciensus support?

    We specialise in cancer, rare diseases and long-term conditions, with the flexibility to design bespoke programmes across multiple therapeutic areas.

    How does Sciensus ensure compliance with regulations?

    Our programmes are built with deep knowledge of European regulatory frameworks and are supported by a unified IT system for accurate reporting and data governance.

    What makes Sciensus different from other PSP providers?

    Our scale, experience and connected ecosystem across Europe – combined with digital innovation and end-to-end expertise – ensure measurable impact for both patients and pharma partners.

     

    Get in touch

    Thank you for your interest in Sciensus. Whether you’re seeking information, partnership opportunities, or want to refer a patient, our dedicated team is here to assist you. Please fill out the form on the right, and one of our multi-lingual representatives will get in touch with you promptly.

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