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.
Clinical use of Investigational Drugs in treatment settings generally involves careful balancing that considers:
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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 when standard treatments prove ineffective. Patient autonomy and informed consent guide healthcare providers in explaining experimental therapy risks, benefits, and alternatives while respecting individual choice in potentially life-saving treatments. -
The need to protect potentially vulnerable patients from unacceptable risks through comprehensive safety protocols and regulatory oversight mechanisms. Clinical trial frameworks evaluate benefit-risk ratios, monitor adverse events, and establish safety stopping rules to prevent patient harm while maintaining access to promising investigational treatments.
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Society's interest in ensuring that treatments for these diseases are developed and approved for marketing to enable broad access by supporting rigorous clinical development pathways. This systematic approach ensures investigational drugs undergo proper FDA evaluation before market authorization, ultimately providing safe, effective treatments for broader patient populations.
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.
Our Specialties
Click on any item below to expand for more details
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Single Patient Expanded Access/Compassionate Use Requests
Individualized programs for critically ill patients who have exhausted standard treatments and need access to investigational therapies. Requires detailed medical justification, regulatory approval, and demonstration that potential benefits outweigh risks for the specific patient's condition.
Learn more: Expanded Access | Compassionate Use
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Multi-Patient Expanded Access Requests or Cohort Protocols
Intermediate programs treating 10-100 patients with similar conditions who cannot access ongoing clinical trials. These cohort protocols streamline the approval process compared to individual requests while maintaining regulatory oversight for groups of patients with comparable medical needs.
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Post-Trial Access
Continuation programs ensuring patients who benefited during clinical trials can maintain treatment access while awaiting regulatory approval. These bridge the gap between trial completion and commercial availability, addressing ethical obligations to provide ongoing care.
Learn more: Post-Trial Access
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Managed Access Programs (MAP Programs)
Structured partnerships between pharmaceutical companies, healthcare systems, and regulators to provide systematic pre-approval access. These comprehensive programs incorporate standardized eligibility criteria, safety monitoring, and real-world evidence collection across broader patient populations.
Learn more: Managed Access Programs
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Compassionate Use Registry
Centralized tracking systems that monitor patients receiving investigational treatments through expanded access pathways. These registries collect safety and efficacy data to support regulatory submissions and inform treatment decisions across multiple stakeholders.
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Investigational Medicinal Product Emergency Use
Rapid deployment pathways for investigational treatments during public health emergencies or crisis situations. These programs involve accelerated review processes and modified risk-benefit assessments to address urgent medical needs when standard regulatory timelines are insufficient.
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Navigating the Regulatory Landscape Within Each Respective Country
Country-specific strategies addressing varying international requirements for expanded access programs. Each jurisdiction has unique approval processes, from FDA pathways in the US to EMA procedures in Europe, requiring tailored approaches that maintain global program coherence while ensuring local compliance.
We Make Expanded Access Easy
How We Help Pharma Companies:
Immediate Compliance
Cost Reduction
Patient Focus
Save Time
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
Cut Costs
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.
Patient Satisfaction
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.
Thank you for all the efforts keeping patients safe and providing us with solutions. I am happy to support your hard work.
The whole EAC team is amazing, very helpful, very professional, and easy to work with. This made a smooth and trustful collaboration between our company and EAC.