Early Access

We are experts in the strategy, design, and implementation
of global early access and unlicensed medicines access programs

Global Early Access Program
– wherever your patients are, Inceptua can reach them.

In addition to truly global individual patient supply route expertise, Inceptua Early Access is also a specialist in the more complex group program approaches. 

Whether it is a US Expanded Access Program (EAP), a French ATU, German Compassionate Use Program (CUP) or a UK EAMS program, Inceptua can manage all of your end-to-end requirements, from protocol development, submissions and interactions with the national agencies, through site set up, monitoring, close-out, data capture and drug supply.

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-testimonials from Merck/Pfizer and other group clients

Broad-Spectrum Early Access Data

Whether it is detailed, real-time metrics on your program, robust outcomes and real-world data, or market access-relevant insights, Inceptua Early Access is set up to maximize the data from your program.

Data generated during your Early Access Program can support:

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-testimonials from Adam Townsend and Paula Albuquerque

Successful Early Access Programs Depend on Detailed Strategic Planning

Early Access is not a ‘box-shifting’ exercise – it is a complex route of medicine provision which dovetails between your clinical development and commercial launch. 

In addition to our collective experience in over 200 early access programs, Inceptua pioneered the pre-program consulting services such as global strategy development and Early Access Feasibility Assessments. These services, and our extensive in-house pharma commercial experience, mean that Inceptua has the breadth of knowledge and detailed operational experience to devise the most appropriate early access strategy for your asset, ensuring your needs, your physicians’ needs and your patients’ needs are taken into account, and ultimately helping you achieve your product launch objectives. 

If you would like to discuss how Inceptua can support you with pre-approval access to your medicines, please either call Inceptua on: +44 203 910 7670, or email at: access@inceptua.com

Early Access Program Transition Specialists

A misfiring Early Access Program is more than just a drain on your resources – it can result in physician frustration, a negative perception of your company amongst your key prescriber base, a loss of goodwill, and ultimately jeopardizes your commercial launch.

Transferring an ongoing Early Access Program to a new vendor can be a daunting prospect – so much so that sometimes the decision may be that it’s better to persist with a non-optimal program rather than risk any potential disruption, but transferring vendors is relatively straight forward, if managed correctly.

Inceptua utilizes its ‘Program Transfer Toolkit’ which capitalizes on its experience in this area to provide a seamless, cost-effective transfer, ensuring minimal disruption for your physicians.

Recognized Industry Thought Leaders

The Inceptua team pioneered now industry-standard services for Early Access (e.g. Corporate Early Access Strategies, Early Access Feasibility Analysis, Compliant Early Access Communications and Early Access-specific RWD collection).

We strive every day to bring new solutions to our clients to support their objectives, and ensure their Early Access Program exceeds their expectations, and seamlessly transitions their asset from pre-approval to launch.

Please refer to our Resources section {hyperlink} to learn more about Early Access.

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About

Mark has specialized in access programs for over 12 years and leads Medicines Access.

Mark Corbett

EXECUTIVE VICE PRESIDENT
MEDICINES ACCESS

About

With over 20 years of industry experience, Stuart leads the consulting arm of our Medicines Access team.

Stuart Bell

VICE PRESIDENT CONSULTING
MEDICINES ACCESS

About

With 20 years experience in the pharmaceutical industry, Ruth leads the implementation of our pre-approval access programs.

Ruth Rostron

VICE PRESIDENT PROJECT MANAGEMENT
MEDICINES ACCESS

About

Kelly has 25 experience in regulatory affairs and quality assurance, 10 of which specializing in Medicines Access regulations

Kelly Fearn

SENIOR DIRECTOR
HEAD OF REGULATORY

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