Pharmaceutical Early Access Programs
Companies that innovate to develop effective new treatments show their commitment to the patients their drugs can potentially help by providing early access. Companies across all geographies have been doing this for decades. The willingness of many sponsors to provide their investigational products to patients at no cost or at the cost of manufacturing is a testament to their action on this public health commitment.
Use of Investigational Drugs in Treatment Settings Generally Involves Careful Balancing That Considers:
- The interests of patients with serious or immediately life-threatening diseases, who need to be able to make decisions about their health care, including using experimental therapies;
- The need to protect potentially vulnerable patients from unacceptable risks;
- Society’s interest in ensuring that treatments for these diseases are developed and approved for marketing to enable broad access
Early Access Care colleagues are deeply rooted in pharmaceutical Research and Development programs. Our team members have held the same responsibilities as pharma companies who reach out for our expertise. You can be certain that we understand the complex considerations before an investigational drug is made available for any early access program. A thoughtful approach and careful planning with a trusted partner, Early Access Care, will enable your program to meet its intended goals.
We focus solely on the end-to-end management and operationalization of early access programs so you can focus on everything else.
Trust our experienced team to streamline this complex process, so patients can gain access to investigational drug treatments faster.
Early Access Care & Pharmaceutical
A Message from Anne B. Cropp, Pharm.D., BS
- Single patient expanded access/compassionate use requests
- Multi-patient expanded access requests or cohort protocols
- Post-trial access
- Managed Access programs ~ MAP Programs
- Compassionate Use Registry
- Investigational Medicinal Product Emergency Use
- Navigating the regulatory landscape within each respective country
We Make Expanded Access Easy
How We Help Pharma Companies
Our experienced team and industry leading platform allow immediate compliance with local country procedures, eliminating delays due to sponsor system development and implementation.
Our experience in drug development and clinical programs give us an edge in rapidly designing and implementing your program.
Real World Data is readily available in several formats to meet publication or submission needs
We manage compassionate use requests so you can focus your internal resources on what’s most important—drug development.
Roll patients over from an ongoing clinical trial into a Post Trial Access program so that you can close your trial when it’s done. This enables trial close-out, timely data analysis, and regulatory submissions while continuing treatment of patients that completed the study.
We work with your clinical investigators to help them bring eligible patients into expanded access and compassionate use programs helping them to assist their patients that don’t qualify for a clinical trial.
We direct eligible clinical trial patients to sites and centers where they can be enrolled into an ongoing clinical study where suitable.
Every request is prioritized and managed efficiently, reducing the time between request submission and treatment implementation.
Want to learn more about our Expanded Access Capabilities?