Averion Core Competencies
Averion provides full-service clinical trials management support throughout the product development lifecycle from first-in-man through to market approval and safety surveillance studies. We pride ourselves on the following core competencies:
- Designing & Implementing Development Programs for Drugs, Biologics and Medical Devices/Instruments
- Enrolling Patients and Monitoring Investigator Sites
- Collecting and Managing Study Data
- Performing Complex Statistical Analysis
- Administering Data Monitoring/Clinical Endpoint Committees
- Writing Protocols, Investigator Brochures, Clinical Trial Reports, Journal Manuscripts, etc.
- Preparing for Agency Review
- Writing and Submitting Regulatory Applications
- Utilizing Technology & Metrics for Performance Measurement and Communications
- Performing Rescue Work (particularly, cleaning & analyzing data)
- Designing & Performing Adaptive Trials
- Performing Post-Marketing and Safety Surveillance Studies
Our Therapeutic Expertise
Averion has a strong therapeutic focus in Oncology, Cardiology, and Medical Devices among others. To learn more about our therapeutic expertise, click here
Our Approval History
Averion assists its medical device, biotechnology and pharmaceutical clients in preparing their programs for FDA review and approval. We are proud of our success rate with the agency, to date, we helped our clients gain NDAs, MAAs, BLAs, INDs as well as PMAs and HDEs. To date, every submission that was accepted for filing, has received approval.