Drug Safety Case Management
Safety Case ManagementSupporting manufacturer sponsors and marketing authorization holders with comprehensive pharmacovigilance services
Designing and implementing a solid foundation for meeting both short-term and long-term case processing needs requires expert guidance. UBC provides clients with that guidance through experts located close to you and your patients, in the United States and in Europe. We support adverse event processing and expedited reporting, according to global requirements. In addition, UBC ensures a complete case processing solution through Argus Safety solutions.
We have experience you can count on. Our expertise in case processing from clinical trials, post-marketing sources, literature, registries, and observational studies will ensure that your safety data set is processed consistently and according to international standards. High quality case processing is key to aggregate analysis and signal detection.
Our capabilities include:
- Spontaneous or clinical trial adverse events case processing
- Case processing for observational studies and registries
- Remote processing in client’s database or UBC’s ARGUS™ database
- Experience with ARGUS™, ARISg™, AERS™, Clintrace™, BaseCon
- Complete or partial processing
- Medical review and assessment by experienced medical team
- 100% quality control
- Follow-up request, tracking, and documentation
- Efficient database hosting solutions
- Legacy case entry and electronic data migration programs
- Proactive updating of case processing conventions with regulatory changes
- Reporting requirements review and tracking by safety regulatory intelligence team
- Global regulatory reporting in E2B, CIOMS, using MedWatch formats, webtrader, gateway, or traditional reporting paths
- Safety Case Management requires processing – and prioritization – of data. UBC focuses on harvesting metrics and monitoring key performance indicators (KPIs) to identify trends and implement remediation in a proactive manner.
- Quality of data entered in safety database rules the quality of data outputs. Thorough aggregate reports and signal detection are the extension of your safety database.
- Your programs are not limited to one location. Our case processing centers of excellence in North America and Europe facilitate proximity to our clients and their patients/prescribers, contributing to enhanced collaboration, covering multiple time zones, and allowing for nearly round-the-clock coverage
- No two products are alike. UBC’s experience in a wide variety of therapeutic areas delivers enhanced narrative quality and lends value to report assessment.
- You choose the level of support your program needs. To help clients manage fluctuation in case volume, UBC offers case processing staff that can serve as an extension of your team, operating under your standard operating procedures (SOPs). This allows you to contain costs while consuming services on a per unit basis.
Commitment to Success
Our numbers tell our story of capabilities and quality. Our Safety Case Management team processed more than 43,000 cases in 2011 and more than 47,000 in 2012.
Contact us to learn more about our scalable pharmacovigilance solutions for North America and Europe.