Early Access Care: An Expert in Managing Expanded Access/Compassionate use

John W. Cropp, PhD, CEO and SVP of Technology
Patients suffering from serious illnesses may require treatment with investigational medications and life-changing therapies that take years to gain regulatory approval. For this reason, government regulatory agencies are working hard to improve procedural efficiency and transparency to allow lawful early access programs. The access programs, referred to as Expanded Access or Compassionate Use, provide seriously ill patients with early access to investigational drugs outside the framework of clinical trials. However, seeking expanded access or creating an early approval mechanism for an investigational drug is a challenging task for pharma companies, physicians, and patients. Pharmaceutical corporations are well-versed in drug development, leading scientific clinical trials to understand an investigational drug’s potential risks and benefits, and ultimately leading to a drug’s approval by government agencies. This being their primary focus, most pharmaceutical companies lack the necessary expertise pertaining to early access programs and navigating required regulations.

Early Access Care fills the gap by developing effective and integrated solutions customized to clients' Expanded Access or Compassionate Use needs; the company specializes in Expanded Access (USA) and Compassionate Use (outside of USA). "By collaborating with biopharmaceutical firms, we intend to make 'Access More Accessible' for patients and their physicians," states John Cropp, CEO, and SVP of Technology of Early Access Care. The company provides comprehensive services to manage expanded access program requests globally, freeing up resources for biopharmaceutical companies to concentrate on the development of new drugs.

Early Access Care is renowned for its wide range of services, such as designing Expanded Access programs and policies, protocol development, end-to-end operational management of global programs, provisioning Early Access Care's eTool, and managing physician requests across the world. The company utilizes the Early Access SystemTM – a proprietary web-based 'all-in-one' software for managing Expanded Access and Compassionate Use requests. The Early Access SystemTM software is an end-to-end eTool customized for each investigational medicine, enabling comprehensive management of Early Access programs across the globe.
Typically, biopharmaceutical companies invest significant time and resource to resolve each Expanded Access request. Early Access requests come from all around the world, and dealing with different governments and health regulations is a highly specialized task. Early Access Care provides extended support, managing the process and serving as a conduit between patients, physicians, and biopharmaceutical companies. It provides insight, expertise, and resources necessary to respond to requests for expanded access. The company's highly skilled team has first-hand knowledge of pharmaceutical R&D, and they understand the problems that arise when resources are pulled away from the daily task of drug development.

With such unmatched core competencies, Early Access Care has ignited several success stories since its inception. In one instance, the company assisted a baby suffering from an ultra-rare neurologic disease in Europe. The company received an urgent request from a pharmaceutical company asking for assistance navigating the emergency early access options to enable expedited treatment for the baby. Within an hour, the team at Early Access Care was providing detailed information on local country regulations, process, and guidance on next steps necessary to deliver the investigational drug to the patient. By leveraging the Early Access SystemTM and the team’s expertise, the pharmaceutical company was able to save the baby's life.

By collaborating with biopharmaceutical firms, we intend to make 'Access More Accessible' for patients and their physicians

From an organizational standpoint, Cropp envisions a future where Early Access Care is a key driver in helping pharma companies, physicians, and patients manage Expanded Access. "We will always continue stoking the fire of innovation to expand the horizons of our services and help our clients guarantee quality and rapid delivery of life saving treatments," concludes Cropp.

Early Access Care

Madison, Connecticut

John W. Cropp, PhD, CEO and SVP of Technology

Early Access Care helps international clients with effective integrated solutions customized to their Expanded Access or Compassionate Use needs

Early Access Care