QVigilance, Quanticate’s new platform, was designed to support sponsors as clinical trials move to post-marketing surveillance and work towards establishing pharmacovigilance (PV) services.
The PV service is the latest investment from Quanticate, a clinical research organization (CRO), as it looks to expand its footprint in the market.
David Hukin, managing director of QVigilance told us, "Life sciences companies have to take increasingly comprehensive steps to assess and monitor the efficacy, safety and benefit-risk balance of their products as regulators continue to improve the safeguarding of patients."
Services like QVigilance allow for the kind of surveillance needed to establish the monitoring of efficacy, safety, and benefit-risk balance for regulation and can provide services necessary to signal regulatory knowledge for approvals.
"Collating and characterizing safety information from a complex and growing number of sources and identifying and evaluating potential safety signals requires extensive regulatory knowledge and is often the driver for outsourcing to specialist third-parties," Hukin continued.
In line with its expansion, the company is growing its PV footprint with additional teams in the UK, Poland, and India. Hukin said, that the expansion is a response to the notable increase in demand for outsourced PV services, "Pharmacovigilance CROs such as QVigilance that have the capabilities to provide global and regional support have the opportunity to become key partners for pharmaceutical, biopharmaceutical, and medical device companies."
Last year Quanticate also made an investment in an additional pharmacovigilance service that enables sponsors to provide continuous evaluation of the risk-benefit profile of products post-market.
The investment in Oracle Argus was made ahead of the update to the European Medicines Agency's (EMA) EudraVigilance system, the European information system for reporting suspected adverse events to medicines in the European economic area.
Quanticate also partnered with CluePoints’ software to establish a service offering for data integrity checks on monitoring and investigator site data. CluePoints is a risk-based monitoring (RBM) and central statistical monitoring solution provider. The new service incorporating CluePoints technology, according to the company, was in response to the ICH Good Clinical Practice (GCP) E6(R2) guidelines.