Global Pharmacovigilance
Averion offers comprehensive global pharmacovigilance solutions for clinical safety, post-market surveillance and risk management or risk minimization plans. Averion's Medical Affairs staff is comprised of experienced clinical professionals who work closely with pharmaceutical, biotechnology and medical device companies to collect, track and analyze the safety profile of their products throughout all the phases of clinical development and post-marketing.
Averion expertly develops a pharmacovigilance management plan that describes in detail the safety processes unique to each client. Averion also provides full database and hosting services that encompass the collection and management of safety data, from database build to validation to international reporting. The safety system is supported and administered by highly skilled Averion technical and medical affairs staff.
Averion is focused on providing our clients with the full support and flexibility they need to meet their international obligations for adverse event reporting. Clients have the ability to access their safety data remotely, anytime, anywhere and in real-time.
Averion's Pharmacovigilance Services include:
- Safety Management Planning
- Safety Database Services - Set-up/Maintenance and hosting
- Clinical Protocol Safety Section Development
- Investigator/Site Training
- Processing of Serious Adverse Event or Unanticipated Adverse Device Effect reports Coding Review
- Coding Legacy Data
- Database Integration or Data Migration
- Reconciliation Services - Safety/Clinical Databases
- Regulatory Dictionary Coding - MedDRA, Sponsor Specific
- Global Regulatory Reporting (Paper or Electronic submissions)
- Safety Reporting to Investigators/IRBs
- Periodic Safety Update Reports (PSURs), Annual Reports or End of Study Reports
- Spontaneous Adverse Event Reporting
- Real-time Ad Hoc Reporting Signal Detection
- Metrics and Compliance Tracking
- Remote access through a secure line
The above services are governed by Averion’s written Standard Operating Procedures and Technical Guidelines and comply with the ICH Guidelines on Good Clinical Practice (GCP).