PVIntegrate™

Our answer to the lack of harmonization of differing pharmacovigilance systems following your expansion e.g., through acquiring companies of varied QMS, SOPs, project KPIs etc. or when you fulfill an ongoing post-marketing requirement (PMR), specific obligations (SOB) or post-marketing commitments (PMC) of previous sponsor companies which may involve clinical trials or observational studies that use RWD.

This is effectively an integration consultancy where due diligence of pharmacovigilance systems, PV systems gap analysis reports, project management oversight and flexible resourcing solutions are provided. PVIntegrate™ offers the opportunity to enhance quality and compliance of processes and to streamline or centralize our client’s relationship with regulators and commercial partners.

Our pharmacovigilance, medical and regulatory experts:

• Establish a transparent and centralized organizational structure with peripheral dependencies at the country level where/if needed. A fully functional reporting system will be developed to ensure compliant and efficient data collection and processing, as well as the detection, assessment, understanding, mitigation and communication of product risks
• Quickly manage PV activities pertinent to launch of, or use an existing patient registry to systematically capture and track data from treated patients with solicited sample collection and follow-up of AEs to resolution to collect additional pertinent data through drug-, setting- and event-based active surveillance
• Assist sponsors to ascertain which party/vendor will hold and maintain global safety databases (GSD) and determine ICSR exchange conditions which will ensure compliance continuity, during marketing authorization transfers (MAT).