Ask Inceptua

Are you in the early stages of thinking about pre-approval access (expanded access, compassionate use etc.)? Would you like to explore the potential pros and cons of pre-approval access specific to your asset, but are not ready yet to engage directly with a vendor?

More and more we find that companies are using intermediaries (from independent consultants to international management consultancies) to answer questions they have around pre-approval access. At Inceptua our experience is that every single pre-approval access program has a unique dynamic, and reliable guidance can only be gained from experience of running hundreds of pre-approval programs, rather than theoretical consultancy.

Ask Inceptua is a free, no obligation alternative service, capitalizing on the Inceptua team’s track record of over 200 access programs, and pioneering of such services as global, corporate strategies on access, program-specific electronic data capture, and detailed feasibility studies.

Common questions we encounter include: Would an access program be a sensible option for our asset at its current stage of development?

• What are the risks associated with providing pre-approval access to our asset and how do we mitigate them?
• How do we ensure that any program does not impact either our ongoing trials or our commercial launch?
• In what countries should we consider opening an access program for our asset?
• What regulatory pathways are open to us and what would be the most suitable approach be in each?
• What do we need to do internally to prepare for an access program?
• In what countries can we capture outcomes data, and how do we do this in practical terms?

We commit to answering up to 10 question on pre-approval access, free-of-charge. Crucially, this is a no-obligation service – we will not follow up with you once the engagement is complete.

Cut out the costs for middlemen – Ask Inceptua: inceptua.com/ask