Expanded Access Programs
Your trusted partner for Expanded Access:
myTomorrows is an experienced leader in managing international Expanded Access Programs (EAPs), which offer an opportunity for patients and their physicians to access a drug ethically and compliantly prior to marketing approval. Our services include strategic guidance, regulatory feasibility & strategy, drug provision, pharmacovigilance services, physician support, as well as reimbursement assistance.
Our team has deep expertise in facilitating safe and compliant access to medicines in development. We use an integrated approach that allows companies to engage with physicians as well as patients, while adhering to increased regulatory complexities. This creates another resource for enhanced patient-centric drug development strategies.
Why consider an Expanded Access Program?
EAPs have become an increasingly important part of drug development strategies. Wider adoption is driven by a growing need for safety, treatment outcomes and other data outside of clinical trials. EAPs offer an opportunity for patients with unmet medical needs and their physicians to access a drug ethically and compliantly prior to marketing approval, while providing a way for companies to better understand the needs of the patient community and their physicians.
Recent regulatory and legislative changes have raised public awareness about accessing medicines in development, while requiring transparency about a company’s Expanded Access policy. This is an opportunity for companies to show their commitment to patients facing unmet medical needs.
Our EAP services:
Designing and launching an Expanded Access Program (EAP) is a time-consuming and complex process that requires specialized expertise. Outsourcing this task has several benefits, including saving you valuable time and resources. Our experienced team can customize the ideal solution for your business.
myTomorrows offers a full range of services to assist with providing patients access to treatments in development. We can support your program and manage all phases, from initial strategic planning and development to execution and marketing approval. Our integrated EAP solution is comprehensive, from patient identification to the distribution of medicine. We partner with our clients to provide tailored solutions to meet your specific needs.
Real-World Data Support
How can Real-World Data work for you?
EAPs offer a distinct opportunity to collect Real-World Data (RWD) in a pre-approval setting. Our dedicated RWD team offers a proactive approach to partner with you and support your program while ensuring that robust data collection adheres to all applicable regulations.
Although EAPs are not a substitute for data collection in clinical trials, they may be supplementary in addressing a variety of research questions. EAPs can yield valuable treatment-related data that could potentially support your regulatory objectives and your reimbursement requirements. We offer strategic guidance into the design, legal, implementational, and regulatory requirements while aligning with your potential commercial and scientific objectives.
How can we support your RWD collection?
myTomorrows has a differentiated RWD collection approach that allows for structured and compliant capture of RWD using our validated Electronic Data Capturing (EDC) system. Our experienced team is equipped with all the regulatory, compliance and legal expertise that is necessary for data management tailored to Expanded Access Programs.
We customize our RWD support according to your program needs. Although the primary goal of Expanded Access is providing medicine to patients with unmet clinical needs, we specialize in data collection as an additional valuable asset.
Patient Finding Support
Our patient finding process:
We lay the groundwork that allows you to immediately engage with pre-qualified patients and their treating physicians who are highly suitable for inclusion in one of your active programs. myTomorrows utilizes several online and offline approaches to assist in the location of patients for Clinical Trials and Expanded Access Programs.
Our step-by-step process involves:
- Non-promotional disease awareness campaigns geared toward patients.
- Patient intake where medical information is shared through a patient portal.
- Treatment Search Reports tailored to a patient’s specific condition and needs.
- Compliant screening process to address eligibility criteria.
- A guided process for patients and HCPs to ensure success.
Why work with us?
myTomorrows offers a personalized approach to identifying potential patients for your clinical trial. Through our personal patient intake process, our medical team is able to connect and build relationships with patients and their physicians through various stages of their diseases. This can bring important insights and add value to your drug development programs. This, along with our automated platform, enables us to find and retain patient populations that can be difficult to find otherwise.
We individually guide each patient and physician through the treatment journey. The in-house team of Patient Navigators informs and assists patients and physicians when seeking treatment options and are supervised by our in-house Medical Doctors. myTomorrows adheres to the strictest patient privacy standards, while facilitating a shared decision-making process that enables you to connect with the patient population for your program goals.