ACCESS SOLUTIONS

Compassionate Use

The use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.

HOW IT WORKS

Responding to a need

Some patients may not qualify to participate in a clinical trial due to the inclusion and exclusion criteria in the protocol. Likewise, patients may not be able to participate in a trial because of geographic proximity to a trial site or because a trial is not being conducted in the patient’s country.

Pharmaceutical companies often receive requests from physicians or patients wanting access to the investigational medicine. There are established regulatory pathways in most countries to supply these patients and Tanner can help.

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OUR ACCESS SOLUTIONS

From Early-Access to Compassionate Use, we take a comprehensive approach to access solutions.

  1. Expanded Access Programs

    US FDA regulated pathways that allow provision of investigational new drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapy and cannot participate in a clinical trial.

  2. Compassionate Use

    The use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.

  3. Post-trial Supply

    A program to maintain supply of the medicine to patients until it becomes commercially available.

  4. Early Access Programs

    Allow pre-approval access to medicines for certain patients

  5. Donation Programs

    Programs for pharmaceutical companies that are seeking to donate their medicines in low- and middle-income countries where patients do not have the insurance or financial means to pay for them.

  6. Drug Shortages

    A service that sets up the infrastructure to respond to supply chain disruptions that can cause drug shortages and mitigate the impact on patient access to their medicines.

  7. Market Withdrawals

    Providing ways to access a market post-withdrawal where demand from physicians and patients remain, and we can help.

  8. Global Access

    We have the ability to access all products for request internationally – finding access to products in unmet demand of markets of need. We do this through NPP (processed through import).

  9. Clinical Supply Gatekeeper

    We can help you effectively manage inbound requests for comparators and reference listed drugs.

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