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Ensuring patient safety is central to your drug/device development

Pharmacovigilance and Medical Device Vigilance

A range of safety services, from turn-key vigilance to QPPV.
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From clinical development through post-marketing activities, our specialist vigilance and safety consultants work with you to ensure your business complies with regional and global regulations and continuously monitor the safety of your pharma products or medical devices.

We help you build a pharmacovigilance or medical device vigilance programme grounded in quality, compliance and efficiency, ensuring patient safety is central to your drug/device development.
Pharmacovigilance
Examples include:
• Managing clinical trial and post-marketing Suspected Unexpected Serious Adverse Drug Reactions (SUSARs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Adverse Events (AEs)
• Turn-key service: receipt, triage, assessment, data entry, QC, MedDRA coding, case narrative, medical review, regulatory reporting, and follow-up of Individual Case Safety Reports (ICSRs)
• Analysis of similar events/signal generation/trending
• Providing monthly activity reports and line listings
• Expert input into responses to regulatory requests and actions
• Provision of the Responsible Person for EudraVigilance
• Maintenance of product in EudraVigilance Medicinal Product Dictionary (XEVMPD)
• Provide highly experienced consultants to be the EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV, including comprehensive 24-hour availability
• Preparation and ongoing management of the Pharmacovigilance System Master File
• Preparation of the EU Risk Management Plan, FDA Risk Evaluation and Mitigation Strategies (REMS)
• Pharmacovigilance/Medical Device Vigilance Training
• Prepare Safety Data Exchange Agreements (SDEAs)
• Preparation and submission of Periodic Benefit-Risk Evaluation Report (PBRER/PSUR), Periodic Adverse Drug Experience Report (PADER), Annual Safety Report (ASR), Annual Report (AR), Development Safety Update Report (DSUR)

Need support for your clinical development project?

Do you need to troubleshoot regulatory or clinical trial issues?

Contact us today for an initial, free-of-charge discussion with a senior consultant about your project-related problems or issues.