Although originally developed for the post-marketing environment, the principles of safety signaling and risk management are now effectively pre-marketing requirements as well. With some modification, safety signaling data sources and methods that are traditionally used in post-approval programs can also be applied to early drug development programs.
Likewise, it is now recommended that major risk management documents such as safety specification (pre-market risk assessment) and pharmacovigilance plans be implemented at the time of ‘first in man’ studies. Risk minimization action plans (RiskMAPs) should be formulated at the time a major risk is first recognized and should not be delayed until Phase III.
The UBC team manages a variety of safety services: safety monitoring and review, collection of follow-up safety information, regulatory reporting and reconciliation of safety data between the safety database and the clinical database.
UBC recognizes the unique need for heightened scrutiny of products in development. We offer a wide variety of services from safety committee development and attendance to traditional DSMB charter design and attendance.
- Premarket safety signaling SOP
- Adverse Event Reporting Plan (AERP)
- Medical Monitoring Plan
- Multi-disciplinary Safety Management Team (SMT)
- Safety sections investigator’s brochure
- Changes in monitoring procedures
- Informed consent
CIOMS VI: Management of safety information from clinical trials
- Traditional safety signaling using ICSRs and serious AE review remains the core of safety signaling for previously unapproved products
- Designated medical events (DMEs)
- Time trending analyses of laboratory, vital signs, SAEs, AEs and other collected data
- Geographical analysis (i.e., by investigative site)
Data and dictionary management
- Development of grouped definitions
- Reference files for signaling
UBC is committed to patient safety. We take a program view of activities so that nothing is overlooked.