UBC provides pharmacovigilance and product safety monitoring support
for clinical research and for marketed biopharmaceuticals, devices
and other medical products. Our experts design and implement
programs to collect, assess, and report safety information for
clinical trials and spontaneous reports of adverse events. UBC’s
pharmacovigilance and safety monitoring solutions include case
processing and development of written periodic safety update reports
(PSURs). We leverage advanced customized technologies that provide
the reliability and flexibility to address the most complex needs.
Our services include:
- Signal Detection & Evaluation
- AE/SAE Monitoring & Reporting
- Data Safety Monitoring Services
- Product Complaint Management
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experiences Reports (PADERs)
