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LONDON (UK) - Quanticate, a leading global data-focused clinical research organisation (CRO) has launched QVigilanceto provide dedicated pharmacovigilance (PV) and risk management services.
QVigilance will be focused on supporting small and mid-size companies transitioning from clinical trials to post-marketing and establishing compliant PV systems.
Quanticate offers the full range of global PV servicesto clinical trial sponsors and market authorization holders (MAHs) in the pharmaceutical, biopharma and medical device sectors including:
· Case processing and reporting
· Global and local literature screening
· Aggregate production and reporting
· Signal and risk management
· Regulatory intelligence and guidance for regional markets.
David Hukin, Managing Director of QVigilance said: “Quanticate is an experienced niche biometric CROsupporting a wide range of customersand we are always working to further our expertise and service offering.
“The launch of Qvigilance is testament to that ethos as we add a dedicated PV service to help ensure our customers achieve and remain compliant with local, regional and global regulatory requirements and guidelines.
“There has been a notable increase in demand for outsourced PV services in the CRO market and there is an opportunity for pharmacovigilance CROs with the capabilities to provide global and regional support to become key partners for pharmaceutical, medical device, neutraceutical and generics companies.”
The company will also provide EU-specific support including EudraVigilance registration and management, creation and maintenance of the Pharmacovigilance System Master File (PSMF) as well as offering an EUQualified Person responsible for Pharmacovigilance (QPPV) to support and oversee client portfolios.
Hukin added: “It is a natural progression for Quanticate to expand its capabilities through the launch a company dedicated to delivering PV services. It’s an area where we have always supported clients and we have the expertise and experience required to contribute to their continued success.”
QVigilance is the latest investment from the organisation as it expands its footprint in the PV market with the continued expansion of PV teams in the UK, Poland (EU) and India. Previous to this there wasan investment into the implementation of the latest version of Argus last year.
Oracle Argus is a fully validated safety database, which enables quality and efficiency in handling safety data. In accordance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), this allows continuous evaluation of the risk-benefit profile of products throughout the product lifecycle.
Please visit https://www.qvigilance.com/for further information.
QVigilance is a global pharmacovigilance (PV) service provider specialized in comprehensive PV and risk management services for small and mid-size sponsors of clinical trials and Marketing Authorisation Holders. Our team is adept in supporting customers transitioning from clinical trials to post-marketing and establishing a compliant pharmacovigilance system to support our customers’ products. QVigilance offers an high-quality and fully comprehensive package of pharmacovigilance and medical device vigilance services, including safety database solutions, case processing & reporting, signal and risk management, regulatory intelligence, QPPV, EudraVigilance, PSMF and PV consultancy for both the global and European market. We are committed in delivering quality-driven PV 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. Please visit the website at www.qvigilance.comfor further information and access to our white papers and resources.
Quanticate is a leading global data focused clinical research organisation (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As experts in clinical data, Quanticate provides high quality teams that offer efficient outsourcing solutions for clinical data management, biostatistics, SAS programming, medical writing, data quality oversight and pharmacovigilance. Quanticate can offer study level support, functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. By offering high quality, value-add client specific solutions to meet current and future development needs, Quanticate has become the supplier of choice for many companies from top tier pharmaceutical giants through to niche biotechnology and device companies. Please visit the website at www.quanticate.com for further information and access to white papers.