Our Expanded Access Program solution
Unlock European opportunities and revenue with Sciensus
Sciensus has a 30-year proven track record in global market expansion, and our team has extensive experience in the rare and orphan disease market.
Our partnership model is designed to support the development and launch of therapeutics in the EU by allowing our partners to leverage our expanded access programs, world class supply chain, patient support programs and nursing programs. We also support biotechs by giving our partners access to our regulatory, marketing and commercial strategy expertise. In the last year alone, we supported our clients with over $350m of sales in Europe. This collaboration can not only ensure a faster route to market but also serves as a significant step in addressing the critical medical needs of patients reliant on timely access to advanced treatments.
Why partner with Sciensus?
Partnering with Sciensus reduces risk and adds value to your European expansion. We believe in making sure every family has access to rare disease medicines and the care they need. No matter where a patient lives or the regulatory governance of that country, we can safely launch and efficiently deliver vital medication and clinical services for families that need it most.
“Our bespoke, fully managed service is designed to meet the specific challenges of launching and delivering orphan drugs for rare diseases and ensure they can access your product, safely and as quickly as possible. Whatever your ambitions, we can quickly scale your business and help many more rare disease patients get the life-changing medication they deserve”. – Andrew Cummins, Director of Expanded Access Programs.
Our comprehensive EAP service offers
Full regulatory assessment
Sciensus will support you with a full regulatory assessment of the countries you are interested in running an access program. This will cover advice on type of access program most suited to your needs, whether it can be charged for or not, what data you may be able to collect. We can also advise on your communication strategy. You will be supported by a dedicated project manager, and a multilingual customer service team.
A digital platform for clinicians (Sciensus Axcess)
We will ensure health care professionals are properly validated and given access to our online ordering portal Sciensus Axcess. Registered healthcare professionals will be able to view documentation for the access program including product information and any relevant training materials.
An established supply chain
Our logistics teams will ensure product is delivered most of the time within 24hrs of order confirmation. We will ensure there is full track and trace capability to allow auditing of all activity. We can provide a full order to cash service. We will deal with any issues in an efficient, ethical and regulatory compliant manner.
EAP monitoring protocol and enhanced real-world data collection
At Sciensus, we excel in designing research protocols to generate real-world evidence, capturing and analyzing real-world data, empowering you to make informed decisions throughout your product lifecycle. Our comprehensive support spans clinical study design, funding submissions, market access initiatives, post-market studies, and product evolution strategies.
A dedicated account manager
A personal touch thanks to a dedicated account manager, a bespoke solution tailored to your specific needs, a strategy developed by our Director of EAP and a dedicated team that will implement it for you.
Our expertise in words
Our experts have put together their years of expertise to provide you with advices on how to unlock your European expansion
Thought Leadership
Navigating expanded access in Europe: a strategic blueprint for biotech leaders
Blog
Accessing and supporting EU rare disease patients: a quick guide
Overcoming challenges in finding rare disease patients in Europe Rare diseases mean rare patients. In Europe ‘rare’ is defined as…
Thought Leadership
Realize your European orphan drug expansion
Schedule a meeting with our EAP expert
To discuss your challenges and create a strategy for accessing Europe tailored to your business needs, please complete the form below. Our Director of Expanded Access Program will contact you to schedule a meeting and provide a complimentary consultation.