PV Outsourcing, Governance & Compliance
Managed PV outsourcing, operating-model and governance support, QPPV and local safety services, PV agreements and intelligence, and explicitly delivered quality/compliance support.
Capabilities in this workflow
Vendors supporting this workflow
Service Provider · +2 more types
Products: D.AI.M.I.
“PLG can run end-to-end pharmacovigilance, including case processing, signal management, periodic safety reports and local safety representation in the countries where your product…”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +5 more
Consulting / Advisory Firm · +2 more types
“We offer comprehensive clinical safety solutions including case processing from intake through regulatory submission, aggregate safety reports, contribution to clinical trial…”Source: voisinconsulting.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +2 more
Products: LifeSphere, NavaX +4 more
“Maintain inspection-ready PSMFs through centralized content management, automated change tracking, and lifecycle controls.”Source: arisglobal.com
Also offers: Safety Database Platforms, PV Automation & AI Case Intake, +3 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“Our pharmacovigilance business is one of the largest groups of PV experts worldwide, with a combination of deep life sciences expertise and best-in-class technologies. So you can…”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +5 more
CRO / Research Services Provider · +1 more type
“At Althian, our pharmacovigilance team provides end-to-end drug safety support — during clinical trials and beyond, into the post-approval lifecycle. We combine deep regulatory…”Source: althian.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +2 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Our flexible approach and commitment to timely case reporting allow clients to use our PV experts to handle all or parts of drug safety reporting responsibilities.”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
Software / Technology Platform · +2 more types
Products: Vault CRM, Veeva RIM +6 more
“…It provides solutions for the management of pharmacovigilance system master files (PSMF), pharmacovigilance agreements (PVAs), risk management plans (RMPs) and additional risk…”Source: veeva.com
Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more
Consulting / Advisory Firm · +1 more type
Products: Twine, Narralytix +1 more
“PV system & process architecture PV organizational design &/or sourcing strategy”Source: bluematterconsulting.com
Also offers: Product Launch Strategy & Readiness, Market Access Strategy & Launch Planning, +2 more
Consulting / Advisory Firm · +2 more types
“Halloran conducts numerous Good Practice (GxP) audits of clinical trial vendors and suppliers, including Laboratories, CDMOs, CROs, clinical supply depots, and safety and…”Source: hallorancg.com
Also offers: Regulatory Development Strategy & Agency Interactions, GxP Compliance Consulting, +2 more