Expanding Access to Life-Saving Treatments

McHade facilitates Expanded Access Programs (EAPs) that provide patients with critical treatments outside of clinical trials. Our end-to-end support ensures that investigational drugs reach patients who have no other treatment options, navigating regulatory requirements and ensuring compassionate use.

Comprehensive Solutions for Compassionate Use Access

Regulatory Navigation

We handle all the regulatory approvals and legal frameworks required to initiate and maintain expanded access programs across various countries.

Patient-Centric Access Programs

Our expanded access programs are designed with the patient in mind, ensuring timely access to investigational treatments for those with unmet medical needs.

Global Coordination and Distribution

We coordinate the global logistics necessary to deliver investigational drugs to patients in need, ensuring seamless distribution regardless of geographic challenges.

Our Aim is to Provide Critical Treatments to Patients in Need

At McHade, we understand the urgency of expanded access programs. That’s why we’ve built a streamlined process to navigate regulatory requirements, manage distribution logistics, and support pharmaceutical companies in making investigational treatments available to patients outside of clinical trials.

Frequently Asked Questions About Expanded Access Programs

What is an Expanded Access Program (EAP)?

An EAP provides patients with access to investigational drugs outside of clinical trials, usually when no other treatment options are available.

How does McHade manage the regulatory process for EAPs?
Our team works closely with local and international regulatory bodies to obtain the necessary approvals and ensure compliance with all legal requirements.
Who qualifies for an Expanded Access Program?
Typically, patients with serious or life-threatening conditions who cannot participate in clinical trials and have exhausted all other treatment options are eligible.
How do you ensure the safe distribution of investigational drugs globally?
We use a combination of trusted logistics partners, real-time tracking, and temperature-controlled transport to ensure safe and timely delivery.
What types of drugs are included in Expanded Access Programs?
Investigational drugs that are still in clinical development, especially those for rare diseases or critical conditions, can be included in EAPs.