Safety & Pharmacovigilance Services

At Curex, we deliver tailored pharmacovigilance services using advanced safety data systems to ensure accuracy, minimize risk, and prioritize subject safety.

Patient Safety through Pharmacovigilance services with CurexBio

Safety Isn’t Optional, it forms the pillar for success of clinical trial.

At CUREXBIO, our end-to-end pharmacovigilance services and expert consulting ensure strict adherence to global regulations and proactive risk mitigation throughout the drug development process. We prioritize drug safety through quality-driven and adaptable solutions, enabling international regulatory compliance. Our specialized pharmacovigilance services help manage safety concerns early, minimizing potential delays and challenges.

Our Expertise in Pharmacovigilance Services Includes:

  • Individual Case Safety Report (ICSR) processing and identification: At CUREXBIO, we ensure accurate collection, processing, and identification of ICSRs to maintain patient safety and regulatory compliance.
  • Regulatory submissions (DSUR, PSUR/PBRER, PADER/PAER, periodic reports) : The basis to meet regulatory standards and compliance, is the timely preparation and submission of periodic safety reports
  • Literature monitoring: To identify potential and emerging safety information for ongoing PV, CUREXBIO supports continuous monitoring of medical and scientific literature.
  • Safety data evaluation and signal detection: To detect safety signals and enabling proactive risk management, CUREXBIO evaluates the safety data on demand.
  • Safety database configuration and oversight (Oracle Argus or client platforms): For ensuring data integrity and compliance with global standards, CUREXBIO configures and manages safety databases.
  • Benefit-risk analysis and risk management planning: To improve patient safety, we perform stringent benefit-risk analysis and implement risk management plans.
  • EudraVigilance assistance : Assuring seamless communication with European Authorities with timely reporting and maintaining compliance with EudraVigilance
  • In-licensed and out-licensed products management: CUREXBIO supports lifecycle management and market compliance by overseeing safety and regulatory obligations for licensed products.

We offer support for clients, ensuring seamless pharmacovigilance management from first-in-human trials to post-marketing phases. Our expert team and recognized processes fulfil compliant, superior safety reporting, constantly and on schedule.

CUREXBIO’s Key Strengths:

  • Expert safety team: A highly qualified team ensures efficient, high-quality case processing.
  • Effective reporting standards: Regulatory-compliant, audit-ready reports with robust KPIs and proven reliability.
  • Rapid case processing: Swift, unblinded ICSR reporting while preserving study integrity.
  • Proactive risk management: Ongoing safety monitoring, signal detection, and literature reviews.
  • Regulatory expertise: Current knowledge of country-specific regulatory requirements.
  • Seamless database transitions: Proficiency in secure, smooth safety database migrations.

 

Our experts offer business continuity through consistent safety reporting and on-time safety operations, enabling clients to focus on advancing drug development programs with confidence—backed by CUREXBIO’s reliable pharmacovigilance services.

Our Expertise Includes:

Why Choose Curexbio for Safety and Pharmacovigilance?

quality

Trusted PV Experts

Dedicated in-house team of experienced PV professionals.
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Tech-Driven Safety

Use of latest safety technologies for streamlined reporting.
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Global PV Compliance

Proficient in global regulatory requirements and electronic systems.
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Timely & Accurate PV

Commitment to timely, accurate, and high-quality PV services.

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