Pharmacovigilance

Thorough collection and assessment of product safety information is essential to the success of both clinical research and in maintaining post-marketing product licenses. With expanding case numbers and complexities due to advanced trials and products, it takes significant effort to fulfill these regulatory requirements.

A global team

Our global pharmacovigilance (PV) team is comprised of safety scientists, physicians, and writers with clinical backgrounds and practice experience. Together they bring deep expertise in safety operations, data migration, electronic transmission of adverse event information to stakeholders according to ICH E2B standards, reporting and regulatory compliance.

With local presence in the Americas, Europe, and Asia Pacific, including substantial resources in China, we have experience working in over 40 countries and continue to expand our reach.

We maintain strong relationships with local health authorities and stay up-to-date on local requirements to ensure compliance with regulatory guidelines. We share our knowledge through peer training with current and prospective clients to support complete safety planning and monitoring practices.

Pharmacovigilance support

  • Facilitated over 200 studies
  • Supported submissions across 15 countries
  • Progressing over 100 ongoing projects to approval

Where safety meets flexibility

We utilize the latest innovations in safety management, have experience with key safety databases including Argus and RSG, and have the flexibility to work with other local platforms. This enables us to tailor our workflows and flex our processes to your established systems, or we can fully run your program on our systems.

Argus

We use Argus version 8.2.3.1, which supports ICH E2B(R3) requirements and is fully validated, per 21 CFR Part 11. In addition, we implement MedDRA upgrades twice yearly after release and can offer complete reporting utilizing the integrated BI publishing tool.

Your safety is secure with Caidya

Supporting with pharmacovigilance consultancy and setup, evaluation and risk management, we offer a range of service options, including full-service for a specific study, standalone services to manage any part of a project, or full outsourcing of your PV function across multiple studies.

As your strategic pharmacovigilance partner, you benefit from a single source of serious adverse event data across clinical trials. This facilitates consistency in coding and evaluation, signal detection, and reference safety information and labeling reviews, and allows for expedited reporting, with the analysis of similar events.

In addition, cost efficiencies can be achieved through the use and maintenance of one set of safety databases and safety management plans.

Backed by a robust QMS

Our comprehensive Quality Management System (QMS) underpins everything we do, allowing us to fully support your audits.

Clinical Trial Pharmacovigilance Capabilities

  • Safety database
  • Data reconciliation of safety and clinical trials databases
  • Medical data review
  • Development of a trial or program-specific safety management plan
  • Preparation and update of risk management plans
  • Serious adverse event (SAE) reporting from sites, including SAE intake, investigator assessment, and source documents
  • SAE/AE case processing, including database entry, medical coding, and customized narrative writing
  • SAE/AE training for investigators and monitors
  • Expedited safety reporting, including MedWatch and CIOMS forms, analysis of similar events, and cross-reporting
  • Periodic reporting, including development safety update reports (DSUR) and IND/IDE annual reports
  • Data safety monitoring board (DSMB) — member selection, meeting support, and coordination
  • Safety review committee
  • Signal detection and analysis
  • Literature review

Post-Marketing Surveillance Capabilities

  • Safety database services
  • Product or program-specific safety management plan/safety manual
  • AE/SAE case management
  • Medical review and assessment of AEs/SAEs
  • Medical dictionary for regulatory activities (MedDRA) and WHO drug dictionary coding
  • Risk Management Plans (RMPs)/REMS
  • Safety review committee support
  • EVDAS (EudraVigilance Data Analysis System) monitoring
  • Expedited and periodic safety reporting
  • Periodic Adverse Drug Experience Report (PADER), Periodic Safety Update Report (PSUR)
  • Signal detection and analysis
  • Literature monitoring
  • Support for Pharmacovigilance System Master File (PSMF) – EU
  • Working with the Qualified Person for Pharmacovigilance (QPPV)
  • Labeling/company core safety data
  • AE reconciliation with sponsor/license partners
Global reach, tailored approaches

Personalized clinical research services

Across every stage of your clinical journey, we’re by your side to help you advance through clinical trials to get your therapy to patients and help bring your science to life.

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Progress your therapeutic breakthrough to regulatory approval with a partner dedicated to supporting your pharmacovigilance activities.

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