Patient safety is not only of paramount importance to UBC, it is at the very core of what we do. UBC provides the expertise and services to meet regulatory requirements and manage risk for our client’s drugs.
We offer a full range of services in this increasingly high-profile area, including:
- Adverse event report collection and processing
- Clinical studies and solicited reporting
- Phase I-IV clinical studies
- Post-marketing programs
- Registries
- Drug
- Disease
- Pregnancy
- FDA-mandated programs
- Spontaneous reports
- Prescription and OTC products
- Call center intake
- SAE and AE processing
- Regulatory reporting
- Periodic reports (PSUR, PAER)
- Core safety labeling/actions
- Drug, biologic, device, vaccine and pregnancy reporting
- Safety systems
- UBC operates the Relsys product, Argus Safety™ Web, an industry standard 21 CRF part 11 compliant safety database.
- UBC has conducted Phase II –IV, safety data capture in the Argus Safety™ Web system for Drug, Biologic and Vaccine products.
- For clients preferring to utilize their own systems, UBC has extensive experience in remote data entry into client databases including Oracle AERS, Clintrace and ARISg.
Signaling is increasingly being used by life science companies to quickly identify and react to safety problems and to help make risk management programs more effective. In addition to post-market surveillance, UBC has unique experience and expertise in pre-market signaling. Pre-marketing signaling is quickly expanding in the biopharmaceutical industry and can have great implications on the method of post-marketing signaling selected, as well as the overall study design.
UBC offers a full suite of services to address all of your safety needs:
- Pharmacovigilance and risk management consulting
- Safety signaling programs (Phase II – IV)
- Clinical data
- FDA AERS and WHO data
- Drug class evaluation
- Risk management data services and reports
- DSMB establishment and management
- Adjudication committees
- Data and dictionary management
- Development of grouped definitions
- Reference files for signaling
- Safety label automation