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Medical Safety

Navigating Pharmacovigilance: Comprehensive Signal, Risk Management & Aggregate Report Solutions

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Aggregate Reports
Signal Management
Risk Management

Aggregate Reports

Classical Services

  • Scheduling
  • Authoring
  • Review (Quality/SME, Medical Review)
  • QPPV Review

Aggregate Universe: PSUR, PBRER, PADER, ASR, ACO, BRER, J-PSUR

Team Expertise: NCEs, Biologics, Combination Product, Generics

Signal Management Process

signal-management

By leveraging advanced technologies and robust methodologies, we detect, prioritize, and evaluate safety signals, ensuring timely interventions and optimal patient outcomes.

Team works with SAS enabaled Quantitative analysis & Physician Grey matter enabaled Qualitative analysis. We are equipped with team of MDs & Scientists to drive your signal at the compliant place.

We have a concept called Signal Detection Algorithm (SDA). Based on product, volume, Region & likelyhood of signals, our experts derive algorithim and creates curated methodology. Such efforts have also been apllauded in recent inspection.

Signal Management Service Portfolio

Classical Services

  • Scheduling
  • Signal detection/Validation from multiple sources
  • Legacy data integration
  • Signal Evaluation Report Drafting
  • Review (Quality/SME, Medical Review) QPPV Review

Team Expertise: NCEs, Biologics, Combination Product, Vaccines, Generics

Risk Management

Our experience in the development of risk management systems is very pragmatic for pharmaceuticals, biosimilars, combination products, vaccines and biologics; this differentiates us from other CROs. Our agile process and experience of working with different size of companies put us as frontrunners when it comes to integration with sponsor’s safety CMO groups in arriving at comprehensive material ready RMPs for submission to the regulatory agency.

COD has team members who worked as expert in managing single shared REMS programs mandated by the FDA. We do provide experts assistance to our manufacturers through REMS development process.

  • Preparation (Core RMP, EU RMP, Local RMP, REMS)
  • SME Review
  • RFI response
  • Risk Minimization Measures (RMM)
    • Development and SME Review of additional RMMs (E.g. Educational Materials, DHPCs)
    • aRMM tracking (per GVP Module XVI requirement)
    • Effectiveness Evaluation report for RMM
  • Single Shared System REMS expert Support

risk-management

Team Experience of more than 09 REMS & 175+ Global RMPs

Introducing COD’s aRMM TREx: The Ultimate aRMM Tracking Solution

Automating aRMM tracking enhances process efficiency and accuracy, offering streamlined audit trails, automatic report generation, and robust data integrity. This ensures compliance, real-time monitoring, informed decision-making, and scalable growth.

At COD, our hands-on industry experts have developed with our software development partner through advanced automation technology.

Why Choose aRMM TREx?

  • Multi-dynamic Technology
  • Process Indicator
  • Highly Configurable & Multitenant
  • In-built Data Migration
  • Robust User Experience
  • Work flow management
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Request for Proposal

By leveraging advanced analytics and regulatory expertise, we empower organizations to proactively manage risks, ensuring compliance and enhancing patient safety throughout the product lifecycle. We invite proposals that align with our commitment to excellence in pharmacovigilance practices