ExTra Access Program
Pre and Post Approval Access Programs
The objective of an Early Access Program is to provide to patients with unmet medical needs an early access to medicines, improving their quality of life prior and post regulatory approval.
In order to achieve this goal, Eurotrials gathered all its own product life cycle experience and expertise to create a cutting-edge service – the ExTra Access Program, which includes:
Cohort and Named Patients Programs:
- Unauthorized medicines (medicines in phase II/III without AIM)
- Authorized medicines (medicines with AIM but without reimbursement)
Our focus is to define an integrated market access and negotiation strategy to accelerate the reimbursement process to payers and policy makers.
As a full-service CRO, we help biopharmaceutical companies to bridge the gap between the product development and product launch in delivering life-saving treatments in challenging conditions. What are the advantages of the Extra Access Program?
- A high-level strategic roadmap to commercialization, transitioning the product from early access program to full market access.
- Helping you to determine the utility of collected data for commercial and medical stakeholders (including real-world value definition, value demonstration, and pricing), and developing evidentiary data for potential reimbursement from payers.
- Generating early “real world access” experience that can be used to help educate physicians in the most effective use of the drug.
- Developing a market-access to support execution in order to achieve optimal considerations based on local, regional and global polices, dynamics, and drivers.
- A strategic direction and evidence generation throughout the development lifecycle, addressing internal and external stakeholders’ needs while shaping, substantiating, and articulation product value.
Besides these advantages, Pre-Approval Programs can have different designations around the world:
Let’s build the future together through an integrated service or a customized solution:
- Local regulatory intelligence
- Strategic design
- Pre-submission meeting preparation and attendance
- Submission of EAP application
- Adapting EAP dossier of others regions
- Supply chain management
- Technical translation
- Periodic reports to authorities
- Compliance with all notification, communication and legal requirements
- Concept development according to regulatory framework
- Protocol development & associated documents
- Clinical study report/clinical trial report)
- Scientific articles reporting Real World Data
- High-level roadmap to commercialization
- Gathering the right quality data of EAP to support reimbursement
- Support market access strategy with data generated from EAP
- Safety & implementation of educational material
- Safety & risk management throughout EAP
- Patients surveillance
- Physicians & sites identification
- Support patient entry activities
- On-going site supports
- Real World Data Collection – safety, effectiveness, patient reported outcomes & use of health resources
- Clinical study database
- Endpoints analyses
- Descriptive statistics
- Statistical analysis
- Data Accurancy