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Pharmacovigilance Services

The collection, storage, analysis, and reporting of all relevant safety and clinical data can be more efficiently handled by a single service. Resolve provides a comprehensive suite of pharmacovigilance Services by integrating the company's extensive biometrics, medical writing, and pharmacovigilance knowledge. Our mission is to assist our clients in meeting all applicable regulations and in effectively managing their products' risk-benefit profiles in order to maximize product potential and patient safety. RM Healthcare delivers solutions tailored to the needs of our clients, whether it be the outsourcing of single tasks or the establishment and operation of a comprehensive worldwide pharmacovigilance system.

RM Healthcare Pharmacovigilance Services

RM Healthcare offers a solution for organizations who value privacy and security but cannot justify the time and resources required to build a fully compliant safety data processing system. We will create, host, and draught your safety database and standard operating procedures.

We ensure compliance with ICH Good Clinical Practices across the whole drug and vaccine development cycle, from Phase I to Phase IV. We're committed to going above and beyond to deliver the Services you need.

RM Healthcare offers the following pharmacovigilance Services:

  • Services in Project Management and Pharmacovigilance Consulting
  • Case Management for Serious Adverse Event Reporting and Follow-Up
  • MedDRA coding
  • Case Narratives
  • Medical Monitoring
  • Globally Rapid Case Reporting
  • Medicinal Product Dictionary (XEVMPD) entry and maintenance
  • Oracle Argus: The World's First Global Safety Database for Safety Information Management
  • Transferring an Existing Case
  • The Detection and Analysis of Signals
  • Submitting a Developmental Safety Status Report (DSUR)
  • Search and Review of the International Literature in Support of the DSUR
  • The Quality Control of Pharmacovigilance, which includes the Creation of Standard Operating Procedures
  • Updates on compliance and progress are provided monthly.
  • Instruction in Pharmacovigilance Awareness
  • Reconciliation of Serious Adverse Events
  • Risk Management
  • The protocol and Investigator's Brochure for the study will be reviewed and revised as needed.

RM Healthcare handles more than 250,000 patient support calls each month