Guiding Pharmaceutical Safe Use

ParagonRx creates comprehensive pharmaceutical safe use programs utilizing standardized, evidence-based methods that enhance patient safety and support commercial success.

Safe Use Success

  • Secure earlier regulatory approval
  • Increase prescriber confidence
  • Lessen healthcare system burden
  • Enhance patient safety, trust, and loyalty

Our Comprehensive Approach

Proactive, Benefit-Risk Optimization » Active, Risk Mitigation » Reactive, Crisis Management

Benefit-Risk Optimization
ParagonRx, together with our inVentiv Health affiliates, utilizes safety surveillance, signal detection, benefit-risk evaluation, and safe use program design in order to proactively identify and address potential risks before they reach a REMS or crisis management situation, thereby allowing for prevention of risks and realization of benefits.

Risk Mitigation
ParagonRx, together with our inVentiv Health affiliates, actively analyzes, designs, plans, intervenes and assesses Risk Evaluation and Mitigation Strategies (REMS) programs that will address regulatory requirements while successfully minimizing the risks of pharmaceutical products for patients.

Crisis Management
ParagonRx, together with our inVentiv Health affiliates, enables pharmaceutical clients to plan and prepare for being reactive and rapidly responsive to adverse events, by designing and executing effective crisis management plans, then guiding appropriate adjustments to that plan.

ParagonRx Press

  • Upcoming webinar Oct. 8 featuring, "Standardizing and Evaluating REMS Report: Review of Draft Report Followed by Panel Discussion with FDA Participants"

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