When patients have a life threatening or debilitating illness, their physicians have exhausted current treatment options or there simply aren’t any treatment options available or they are unable to enter a clinical trial:
Mechanisms exist across the globe to enable access (pre-approval access, managed access, compassionate use, expanded access) to medicines where they are not approved in the country of intended use.
Healthcare professionals often seek to access these medicines for their patients and biopharmaceutical companies developing innovative medicines are increasingly making these medicines available to patients through early access programs.
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 300 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.
Broad-spectrum Early Access data
Inceptua can support your Early Access data requirements, whatever they might be.
We can manage all aspects of your data collection:
- Detailed outcomes data (collecting real-world evidence from the first patient population outside of your clinical trials),
- Patient-reported outcomes,
- Physician perception data to feed into your commercial launch (perception of product, likelihood of prescribing, issues with dosing, administration or adherence),
- Real-time access to detailed program metrics,
- … and more
Let us help you maximize the data returns on your program.
Data generated during your Early Access Program can support:
- Program modifications
- Program expansion
- HTA submissions
- Market access
- Publications
A misfiring Early Access Program is more than just a drain on your resources – it can result in physician frustration, a negative of your company amongst your key prescriber base, a loss of goodwill, and ultimately it can jeopardize 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 is better to persist with a sub-optimal program rather than risk any potential disruption.
However, transferring vendors is relatively straight forward if managed correctly.
We utilize our ‘Program Transfer Toolkit’ which capitalizes on our experience in this area to provide a seamless, cost-effective transfer, ensuring minimal disruption for your physicians and uninterrupted supply of medicines to your patients.
- We have provided much-needed medicines to patients across Europe, North America, Latin America, Asia Pacific, the Middle East and Africa.
- In addition, we are also a specialist in the more complex group program approaches.
- Whether it is a US Expanded Access Program (EAP), a French AC/AP, German Compassionate Use Program (CUP) or a UK EAMS program, we 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.
Our team pioneers 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.
- Ensure their Early Access Program exceeds their expectations.
- Seamlessly transitions their assets from pre-approval to launch.