Additional Early Access Services
Early Access Care offers customized services supporting early access programs.
We advocate for early strategic collaboration to assess right-sized services that will best support your program goals. These include:
- Consulting on early access strategy and program design
- Customized phase-approach addressing all phases of asset life cycle
- Medical writing, including protocol development
- Global Regulatory expertise
- Medical Monitoring
- Real world data support of regulatory dossier
- Global storage, labeling and distribution services
- Trial Master File
- Central IRB/ERB
- Safety / Pharmacovigilance support
- Engagement with patient and care provider community
- Community education and awareness
- Webinar development with national physician and patient communities
- Scientific Congress support
- Transition to commercial product
- Comprehensive data management services
Patient Voice And Advocacy
At the core of our company is the patient voice - we listen and learn to truly understand a patient’s condition, their unique personal experience and specific needs as part of patient engagement. Early Access Care understands the importance of patient insights in designing an early access program, and carefully listening to the patient journey. In many conditions, the patient care provider is an equally important element.
Our Involvement In Patient Advocacy Can Include The Following:
- Collaboration with patient community on protocol, eligibility criteria, and standard of care
- Incorporating the patient voice throughout early access communication and patient facing materials
- Community education
Case Study – Patient Voice
EAC was asked to meet with a patient community to develop an early access protocol with insights to the patient experience in a neurodegenerative condition where the patient voice and community was not well defined. EAC brought together individuals at various stages of disease, and in some cases care providers, to engage in a panel discussion. Participants were carefully screened to ensure balanced perspective. EAC carefully listened to unique personal experiences important in the conduct of the early access program that may otherwise not be optimized. Patient and care provider insights were incorporated in the early access protocol. The overall result was that patients and care providers had a direct impact on the inclusion criteria of the protocol, as well as the Visit Schedule. Participants were also involved in the Informed Consent development and patient facing materials. The participants learned about early access and more importantly, created a protocol that heard and reflected the patient voice.
Case Study – Physician Education
Early Access Care was present to speak with Health Care Providers (HCPs) and patients at 3 major scientific meetings within 6 months of Expanded Access program launch. This posed an opportunity to educate HCPs and patients about expanded access for those interested in learning more. This was scientific community not previously engaged in Expanded Access.
Global Storage, Labeling And Distribution Services
Early Access Care is a full-service provider of warehousing, labeling and distribution services, all fully GMP compliant.
Labeling: We provide a full-scale labeling service. Labeling requirements will differ by country, and we manage single panel and multi-country booklet labeling with country translations in compliance with local labeling requirements.
Depot / Warehousing: Early Access Care will work with your clinical supply team to develop the optimal plan for the anticipated country distribution in the early access program or post-trial program. Programs can be customized to use our depots or the client depot.
The drug supply for a specific patient is secured, selecting from commercial pack or investigational drug, depending on regulatory pathway for a client’s specific program.
Early Access Care has the supply solution best suited to your program.
Want to learn more about our Expanded Access Capabilities?