At the forefront of good PV practices
Ongoing monitoring of product safety is paramount from the earliest stages of pharmaceutical development and throughout the product life cycle. However, understanding and implementing good pharmacovigilance (PV) practice can be a challenge. Our team of highly qualified PV specialists will guide you through the entire process, from proactive risk consideration to post-market PV systems, in order to ensure that absolutely nothing is missed. Our long experience means we can offer fast and reliable development of safety management plans with smooth execution.
Medical expertise when it matters most
Our Medical Monitoring team consists of highly competent medical doctors who have gathered a significant amount of experience in various therapeutic areas throughout the years in Phase I-IV studies. As part of our strategic partnership with you, our team will apply their medical expertise to produce robust risk mitigation strategies. They are also well equipped to review clinical data and provide input into corrective action plans.
Technology that powers your development
Many of the challenges with implementing good PV practices can be overcome with the smart integration of transformative technology. Our clinical safety management staff can assist in setting up a safety database from an external vendor of your choice. When integrated with the radical Viedoc™ EDC system it will be smooth and efficient handling of Serious Adverse Events, even from the investigator’s perspective. The external safety database that LINK Medical normally uses when a safety database is requested, is E2B and CFR21 part 11 compliant and has an integrated submission management tool for direct entry, complex search functionality, and simplified signal detection. It enables E2B-compliant XML file import and export, recording of Individual Case Safety Reports (ICSRs), and the generation of useful documents including MedWatch forms.
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Overview of Pharmacovigilance Services:
Early development
- Medical Monitoring input to protocol and design
- Risk assessment of the product
Clinical development
- Adverse Events (AE)/Serious AE (SAE) processing
- Recording in the Safety Database
- Query management and follow-up
- MedDRA coding
- Case Narrative writing
- Medical data review
- Handling of SUSARs
- Preparing and submitting DSUR
- Generating line-listings, CIOMS 1 format reports and MedWatch forms with our safety database
- Tabulating summaries
- Timely and quality full-scale processing of Individual Case Safety Reports (ICSRs)
Medical Monitoring
- Study-specific training when needed, for instance in-depth training on the therapeutic area or in the investigational medicinal product
- Assisting project managers in identifying the key risks to data that are critical to the primary objective, and providing medical input into risk mitigation strategies
- Developing Medical Monitoring Plans
- Supporting study teams, investigators and sites with medical expertise
- Medical input into adverse event handling, including review of cumulative SAE listings and any other emergent safety information
- Reviewing clinical data and the critical parameters of studies
- Providing input into corrective actions plans
- Medical coding of AEs and medications
- Preparing training material for Investigators and attending Investigators’ meetings
- Providing medical input into regulatory submissions, if required
Post-Marketing
- Pharmacovigilance System set-up and developing/maintaining the Pharmacovigilance System Master File (PSMF)
- Regular global and local literature monitoring
- EudraVigilance support, including mandatory ongoing medicinal product data reporting to XEVMPD
- Ongoing safety surveillance, signal detection validation, evaluation and further processing
- Risk management, including developing Risk Management Plans (RMPs) and handling risk minimization measures
- Developing and submitting Periodic Safety Update Reports (PSURs)
- Pharmacovigilance audits and inspections handling
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