Q2 Drug Safety is your full service pharmacovigilance provider with tailored offerings to match your requirements for adverse event case management, medical writing, risk management and governance.
Q2 Drug Safety case management utilizes fully E2B (R3) compliant databases and touches on all phases of your products life cycle from clinical development through post-marketing activities. You will have peace of mind as your product evolves from cradle to retirement (death).
By incorporating our Qscopic tool, the team of expert medical writers produce a wide range of aggregate reports and identify benefit – risk characteristics leading to the development of quality risk management plans.
Our experience in developing signal detection processes and statistical analysis combined with the medical expertise, Q2 Drug Safety optimizes the use of medical and epidemiological resources in efficient manner to detect growing trends and eliminate false signals.
Q2 Drug Safety works with you to develop training plans, ensure inspection readiness, develop and maintain the PSMFs and SOPs
Qscopic is a newly developed web-based tool specifically designed to address the need for systematically generated regulatory compliance safety reports (e.g. DSUR or PSUR / PBRER) as well as ad hoc safety reports.
Available tools are typically unable to manipulate a wide range of line listing and summary tabulations as demanded by regulatory agencies, or for signal detection and responses to ad hoc safety inquiries.
Qscopic, in response, was developed along with PV professionals to compensate this vacuum and achieve high quality safety reporting.
Web-based design for PV professionals; safety reporting has never been easier
Intuitive step-by-step report construction or fast report generation using a template
Controlled and validated regulatory compliance report directly from the system and ready for submission
Approved significant reduction on manpower and/or money for report generation
A WEB-BASED SAFETY REPORTING TOOL
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