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Pharmacovigilance Services

There is an advantage in centralizing all safety data, clinical data, analysis and reporting with one provider. By combining Quanticate’s substantial biometrics, medical writing, and pharmacovigilance expertise, we offer a fully compliant and high-quality complete package of pharmacovigilance services. Our goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximise product potential, whilst ensuring patient safety. From outsourcing of individual activities to the setup and management of an effective and efficient global pharmacovigilance system, Quanticate provides solutions specific to the requirements of our customer’s organization and products.

If you would like to have control over your safety data but do not want the cost and delay of setting up a compliant safety processing system, Quanticate has an alternative. We can set up and host your safety database and write your SOPs. We have Oracle Argus in place and provide routine and ad hoc outputs for oversight of your safety data. We also utilise our iQ customer portal where data and documents can be easily shared. If you want to outsource any part of the adverse event management process we can help you as needed.

pharmacovigilance database compliance webinar

From Phase I to IV we cover drug and vaccine safety right through to the development cycle ensuring that ICH Good Clinical Practices are fulfilled. We have a passion to provide excellence and solutions for the services you require.

Quanticate offer the following pharmacovigilance services:

  • PV Consultancy and Project Management
  • Serious Adverse Event Case Processing of Initial/Follow-up reports
  • MedDRA coding
  • Case Narratives
  • Medical Monitoring
  • Global Expedited Case Reporting
  • EudraVigilance reporting using EVWEB
  • Responsible Person for EudraVigilance
  • Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) entry and maintenance
  • Safety Data Management & Global Safety Database - Oracle Argus
  • Legacy case transfer
  • Signal Detection & Evaluation
  • Development Safety Update Report (DSUR) preparation and submission
  • Global Literature Search & Review in support of the DSUR
  • Pharmacovigilance Quality Assurance including SOP development
  • Monthly compliance and status reporting
  • Pharmacovigilance Awareness Training
  • Reconciliation of Serious Adverse Events
  • Risk Management
  • Study documentation review and update, including protocol and Investigator’s Brochure

It is our objective to ensure the risk-benefit profile of products is monitored, in order to maximise product potential, whilst ensuring patient safety. We will support and maintain your quality assured Pharmacovigilance System to regulatory standards.

 Quanticate offer the following post-authorisation services:

  • PV Consultancy and Project Management
  • Individual Case Safety Report (ICSR) Processing of Initial/Follow-up reports
  • MedDRA coding
  • Case Narratives
  • Pharmacovigilance Physician services
  • Global Expedited Case Reporting
  • EudraVigilance reporting using EVWEB
  • Responsible Person for Eudravigilance
  • Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) entry and maintenance
  • Safety Data Management & Global Safety Database - Oracle Argus
  • Signal Detection & Evaluation
  • Periodic Safety Update Report (PSUR) preparation and submission
  • Global Literature Search & Review
  • Local literature review
  • EU Qualified Person for Pharmacovigilance (QPPV) and deputy
  • Pharmacovigilance Quality Assurance including SOP development
  • Monthly Compliance and Status reporting
  • Pharmacovigilance Awareness Training, Safety Data Exchange Agreements (SDEAs) and reconciliation of ICSRs with partners
  • Risk Management Plan production, review and maintenance
  • Pharmacovigilance System Master File (PSMF)
  • Company Core Safety Information (CCSI) production and maintenance
  • Regulatory Intelligence

Quanticate provide a full range of device vigilance services in support of both device clinical studies and post-authorisation needs. Our team of vigilance experts are well versed in the differing requirements for CE-marked and non-CE marked devices, Implantable Medical Devices, In Vitro Diagnostic Medical Devices and drug-device combination products following both EU MEDDEV guidance and FDA 21 CFR 803 and 812 standards.

Quanticate offer the following medical device vigilance services:

  • Medical Device Consultancy and Project Management
  • Adverse Device Effect (ADE) / Medical Device Incident (MDI) Case Processing, coding and follow-up
  • Case Narratives
  • Safety Data Management & Global Safety Database
  • Signal Detection & Evaluation
  • Device Vigilance Report Preparation & Submission
  • Medical assessment
  • Literature Search & Review
  • Vigilance Quality Assurance including SOP development
  • Monthly compliance and status reporting
  • ADE and MDI Reconciliation
  • Field Safety Corrective Action (FSCA) generation and submission
  • Creation and distribution of Field Safety Notices (FSNs)
  • Periodic reporting

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Thanks so much for always keeping me completely in the loop, always keeping projects on track, always knowing exactly what is going on and consistently delivering high quality deliverables! You are amazing and I’m so lucky to have you on my team.

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