Expanded Access Program (EAP) Solutions
Our strategic design and implementation of tailored, value-added EAPs not only provide early access to therapies to patients with unmet medical needs, they also enable greater stakeholder connectivity and offer sponsors the opportunity to gather valuable Real-World Data that can assist with licensing and product commercialization.
Expanded Access Program (EAP) Solutions
Our strategic design and implementation of tailored, value-added EAPs not only provide early access to therapies to patients with unmet medical needs, they also enable greater stakeholder connectivity and offer sponsors the opportunity to gather valuable Real-World Data that can assist with licensing and product commercialization.
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Our team works with you from concept and strategy to design and full implementation of EAP solutions, primed for efficiency, accuracy and stakeholder engagement, while targeting improved patient and commercial outcomes. As a full-service provider, we support sponsors across the whole range of services required for a successful delivery of an expanded access program. Our proprietary technology platform for Real-World Data collection and insights can help streamline your product's journey to commercialization.
Asset-Centric EAP Design
We understand the value and importance of your drug asset. Our team consults with you at length to understand your commercial and product objectives, and to identify the needs of all connected EAP stakeholders. We take a strategic and personalized approach to program design to meet the identified needs, relying on 25+ years' experience of delivering successful EAPs that optimize the benefits, while reducing the risks.
Asset-Centric EAP Design
We understand the value and importance of your drug asset. Our team consults with you at length to understand your commercial and product objectives, and to identify the needs of all connected EAP stakeholders. We take a strategic and personalized approach to program design to meet the identified needs, relying on 25+ years' experience of delivering successful EAPs that optimize the benefits, while reducing the risks.
Best-in-Class EAP Support
We have put together a team of seasoned experts focused on specialty drugs, rare diseases and oncology, and with wide-ranging EAP and industry experience. We have equipped them with our proprietary, purpose-built, industry-leading Real-World Data (RWD) collection and analysis technology. Our physical warehousing and distribution infrastructure in the U.S., EU and the U.K. is world-class. We supplement the sponsor's internal resources and infrastructure to deliver an EAP with a truly global reach and outstanding white-glove stakeholder support.
Best-in-Class EAP Support
We have put together a team of seasoned experts focused on specialty drugs, rare diseases and oncology, and with wide-ranging EAP and industry experience. We have equipped them with our proprietary, purpose-built, industry-leading Real-World Data (RWD) collection and analysis technology. Our physical warehousing and distribution infrastructure in the U.S., EU and the U.K. is world-class. We supplement the sponsor's internal resources and infrastructure to deliver an EAP with a truly global reach and outstanding white-glove stakeholder support.
Global Regulatory Expertise in Early Access Programs
Complex and distinct regulatory frameworks define the global expanded access program, landscape and often present planning and implementation challenges. Our team has unparalleled knowledge of country-specific regulations and navigates them in a compliant and timely fashion, steering EAPs to success, while adding value and reducing risk. From development of a global regulatory strategy, to providing local hands-on regulatory services, our regulatory team stands by our clients at every step of the way, treating their investigational new drug with "white-glove" service.
Global Regulatory Expertise in Early Access Programs
Complex and distinct regulatory frameworks define the global expanded access program, landscape and often present planning and implementation challenges. Our team has unparalleled knowledge of country-specific regulations and navigates them in a compliant and timely fashion, steering EAPs to success, while adding value and reducing risk. From development of a global regulatory strategy, to providing local hands-on regulatory services, our regulatory team stands by our clients at every step of the way, treating their investigational new drug with "white-glove" service.
World-class Global Distribution of Investigational New Drugs
Durbin can hold stock, deliver and manage all distribution from our fully owned and secure global warehouses to hospitals and pharmacies across the world. We manage the entire end-to-end process, taking full accountability through to product delivery. Our team of unlicensed product distribution specialists has experience with a wide range of drug types from chemical entities to biologics, including cell and gene therapies and controlled drugs under a wide range of storage and shipping conditions.
World-class Global Distribution of Investigational New Drugs
Durbin can hold stock, deliver and manage all distribution from our fully owned and secure global warehouses to hospitals and pharmacies across the world. We manage the entire end-to-end process, taking full accountability through to product delivery. Our team of unlicensed product distribution specialists has experience with a wide range of drug types from chemical entities to biologics, including cell and gene therapies and controlled drugs under a wide range of storage and shipping conditions.
Powerful RWD Technology to Fuel Your Expanded Access Program
Insights from RWD can often complement data gathered from randomized clinical trials (RCTs) and are increasingly accepted to support decisions by regulators and payors. Highlighting real-world patient and healthcare provider (HCP) experiences, RWD can also add significant value to your product development and planning. uniphi, our robust proprietary RWD platform, is a one-stop solution for program management, enrollment, drug supply management, compliant capture of RWD and patient-reported outcomes. The cloud-based technology is instrumental in truly improving efficiency of EAP processes for HCPs, sponsors and patients, and ultimately driving the success of your expanded access programs.
Powerful RWD Technology to Fuel Your Expanded Access Program
Insights from RWD can often complement data gathered from randomized clinical trials (RCTs) and are increasingly accepted to support decisions by regulators and payors. Highlighting real-world patient and healthcare provider (HCP) experiences, RWD can also add significant value to your product development and planning. uniphi, our robust proprietary RWD platform, is a one-stop solution for program management, enrollment, drug supply management, compliant capture of RWD and patient-reported outcomes. The cloud-based technology is instrumental in truly improving efficiency of EAP processes for HCPs, sponsors and patients, and ultimately driving the success of your expanded access programs.
