ExTra Access Program

Pre and Post Approval Access Programs

Early Access Programs are designed to provide patients with unmet medical needs an early access to medicines all over the world, improving their quality of life prior and post regulatory approval.

Being a worldwide concept, Pre-Approval Programs can have different designations around the world:

 

With strong local expertise in Europe and Latin America, Eurotrials gathered all its own product life cycle experience and expertise to create the ExTra Access Program with a Real-World healthcare resource use. Our focus is to define an integrated market access and negotiation strategy to accelerate the reimbursement process to payers and policy makers, through multidisciplinary teams.

The ExTra Access Program, which includes Cohort and Named Patients Programs:

  • Unauthorized medicines (medicines in phase II/III without Marketing Authorization)
  • Authorized medicines (medicines with Marketing Authorization but without reimbursement)

 

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.

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