About QVigilance

WHO WE ARE

Pharmacovigilance
Contract Research Organisation

QVigilance is Quanticate' sister company specialized in providing comprehensive pharmacovigilance (PV) and risk management services for Sponsors of clinical trials and Marketing Authorisation Holders

“We strive to exceed our customers’ expectations and ensure our customers remain compliant with local, regional and global regulatory requirements and guidelines"

Adept in supporting customers transitioning from clinical trials to post-marketing and establishing a compliant pharmacovigilance system to support our customers’ products.

We are committed to delivering quality-driven pharmacovigilance services and working collaboratively and flexibly with our customers. Together, we work towards continuous improvement in our understanding of benefit-risk profile of our customers’ products and thereby safeguard patients.

David Hukin
HEAD OF PHARMACOVIGILANCE

Corporate Values

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Quality Driven

Striving to continuously meet regulatory requirements and exceed the expectations of our customers through careful planning and robust quality control practices

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Robust Processes

Solutions underpinned by comprehensive inspection-ready procedures maintained within an audit-trailed quality management system

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Tailored Solutions

Flexible services to meet the specific vigilance needs and integrate seamlessly with our customer’s company structure, systems and processes

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Collaborative Partnerships

Sharing common standards and goals with our customers and working with openness, transparency and accountability to ensure mutual respect and satisfaction

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Agile Team

Maintaining an experienced and adaptable team kept up to date with the latest requirements capable of taking on challenging projects and solving complex problems

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Proactive Improvement

Continuously drawing on our expertise and feedback from our customers to ensure our people, systems and processes deliver high quality, effective and efficient services

Our Pharmacovigilance Expertise

QVigilance Timeline

2010 - our Pharmacovigilance team was founded and secured our first customer

Our Pharmacovigilance team was established and our Safety Database hosting solution went live with the implementation of Argus 5.1

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2012 - Implementation of new EU Pharmacovigilance Legislation

The new eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) supported

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2013 - Signal and Risk Management procedures in place

Ongoing and periodic signal detection and risk management procedures were implemented in accordance with Good Pharmacovigilance Practices (GVP)

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2014 - PSMF and EU/ Local QPPV service provision initiated

The Pharmacovigilance System Master File is a legal requirement for any medicinal product authorised in the EU. The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that the MAH’s Pharmacovigilance system is compliant with EU requirements

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2015  - EMA Medical Literature Monitoring service supported

QVigilance can monitor and review the Eudravigilance Medical Literature Monitoring (MLM) service, maintained by the EMA, for ICSRs identified in the literature if the customer’s product is included in the list of active substances covered by the MLM service

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2016 - ISO 9001 Quality Management Accreditation

The ISO 9001 is the internationally recognised Quality Management System (QMS) standard certification designed to be a tool for continually improve, streamline operations and reduce costs.

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Jan 2017 - Regulatory Intelligence formal activities initiated

QVigilance continuously monitors regulatory information from local, regional and global authorities and organisations for PV-related regulatory intelligence to ensure that we and our customers are always up to speed and thereby maintain compliance with the latest regulatory
requirements

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Aug 2017 - ARGUS 8.1 goes live

Version 8.1 we currently use offers a complete safety database solution, its main features include: global case processing, signal detection, detailed analytics, electronic case intake, electronic expedited reporting, risk management, periodic reporting and submissions; as well as the capacity to hold large volumes of cases and associated source records.

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Sep 2017 - Partnership with ESMS (Medical Information Provider) established

Available 24/7, ESMS provides medical information enquiry handling for authorised products that are tailored to suit the specific needs of each client and their product(s). Our partnership with ESMS ensures that Medical Information is provided as it would be from a client's own medical information department. 

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2018 - EVDAS monitoring service provision initiated

QVigilance can monitor the EudraVigilance Data Analysis System to the extent of MAH access and download electronic Reaction Monitoring Reports and EVDAS line listing reports for use in the detection and evaluation of safety signals and benefit-risk analysis.

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May 2018 - David Hukin new Managing Director of Pharmacovigilance 

The addition of David to the QVigilance team provides us with the leadership and experience to expand our range of services in Pharmacovigilance to better service our client’s needs

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QVigilance Global Pharmacovigilance Coverage