Sciformix Corporation

Sciformix is a knowledge based global service provider for the Pharmaceutical and Biopharmaceutical industry. We partner with our clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Our areas of specialization are Safety and Risk Management, Biometrics, Scientific Writing, and Regulatory Affairs.
Our Safety and Risk Management services, that span the entire spectrum of the drug lifecycle, will help you analyze the benefit – risk profile of your product as well as identify and bridge the gap between peri approval and commercialization.
Our signal detection and signal management services employ both qualitative and quantitative methods to identify signals and anticipate potential risks so as to propose and implement solutions that maximize the benefit of the drug while proactively managing its safety. Our safety specialists and regulatory strategists will help you identify potential regulatory concerns and will help you address them comprehensively by developing a Risk Management Plan.
Our services Include:
Individual Case processing services
• Triage
• Data Entry
• Case review
• Medical review (including causality assessment)
• Submission to regulators
Aggregate Reporting
Signal Detection
Risk Management
• Develop RMPs, REMS and RiskMaps
• Develop and implement tools for risk management
Access to QPPV services