Decentralized, Virtual, and Hybrid Clinical Trials

Live Panel Session

Thursday, Mar 11, 2021 | 12:00pm – 1:30pm Eastern

Thursday, Mar 11, 2021

Craig Lipset Founder, Clinical Innovation Partners

Craig Lipset

Clinical Innovation Partners

Ax-S Pharma is the leading education resource on Expanded Access to new medicines, worldwide.

Not since the AIDS crisis has the public been made so aware of an emergency need for exploratory treatment options as we now face in the COVID-19 pandemic. EA Programs for convalescent plasma and Remdesivir have each treated thousands of people with serious COVID-19 symptoms, but health systems around the world can do better.
The fusion of clinical research and modern healthcare delivery

February - March 2021

Our series of 4 panel-session webcasts, accredited education videos, group discussions, and additional multi-media resources together in a single virtual conference environment, throughout February and March.

Register now to gain 24/7 access to all programming, video-networking, and exhibits.

5 Core Topics

Ax-S Pharma brings together world leaders from industry, medicine, and policy centers to provide members an unparalleled range of information and perspective on the integration of research and healthcare.

Earn CME Credits

Our programming includes accredited material for Continuing Education

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Become a member to gain access to Videos and Publications in addition to Special Event Invitations and our Newsletter

Basic Membership

Premium Membership

The Expanded Access Summit®, our flagship event, is the world’s largest annual conference on pre-market access to medicines.  The Summit focused on feasibility for all stakeholders and the integration of well-designed access programs in the modern clinical development process.

Expanded Access Explained

Global and Large Scale

Most countries allow “treatment-use” of new pre-market medicines for serious unsolved health conditions. Since 1987, Expanded Access Programs in the U.S. have been used to treat more than 250,000 patients in a range of serious diseases.

In Harmony with Ongoing Research

EAPs have been used widely to enroll large numbers of on-label patients who are outside the inclusion/exclusion criteria of a product’s research trials.  Properly designed Expanded Access trials or “Expanded Access programs” (EAPs) have also helped to recruit and retain eligible patients in research trials, and in many cases generated structured data that sped the development and market approval of the particular product.  Despite widespread misconception, we have found no evidence of an authorized EAP impeding the enrollment of any research study or negatively impacting clinical development of the particular product.

Bringing Inclusivity to Clinical Development

Expanded Access regulations require that treatment is the primary objective in these programs and therefore grant EAP sponsors privileges that would not be appropriate for research trials. Compared to the cost of clinical research, the per-patient cost of Expanded Access can be very low. To learn more about the regulation, history, or best practice of Expanded Access in any country, contact us here. 

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