risk management and signal detection …...risk mitigation and management strategies rems...
TRANSCRIPT
RISK MANAGEMENT AND SIGNAL DETECTION SOLUTIONSComprehensive solution from identi�cation and assessment of safety signals to development of strategies for risk reduction and implementation of a risk management plan
INDEGENE CAPABILITIES
Core and local RMP preparation and update
Development of educational materials/questionnaires as additional risk minimization measures
Bene�t-risk assessment, safety pro�le assessment, and medical assessment
Risk mitigation and management strategies
REMS Preparation
Signal Detection from various sources
Line Listings assessment from the safety database for D-E pair analysis
Preparation of signal management SOPs, WIs, process �ow, etc.
Detection, prioritization, validation and evaluation of safety signals using qualitative and quantitative methods and algorithms for routine and heightened surveillance
Signal Report preparation for signal review committee
Additional Monitoring tracker and recommendations
RISK MANAGEMENT SIGNAL DETECTION
INDEGENE VALUE PROPOSITION
NICHE AND NUANCED
EXPERTISE
DEEP THERAPEUTICEXPERIENCE
TRACK RECORD ACROSS PRODUCT RANGE
REGULATORS ACROSS
THE GLOBE
[email protected] W www.indegene.com +1 732 750 2901P +1 732 750 7990FIndegene, 150 College Rd W, Suite 104, Princeton, NJ 08540
TRACK RECORD
GlobalClients
Automated and rule-based Data Platform
Years ofPartnership
Per YearRMP/REMS
Per Year Routine and Heightened
Surveillance
8+ 4+ 300+ 1000+
TECHNOLOGY DIFFERENTIATOR
AI and rule-based Signal Evaluation
Automated and rule-based Workflow Management