Aggregate Reporting, Benefit-Risk & Risk Management
Compare vendors for aggregate reporting, benefit-risk & risk management within Pharmacovigilance & Drug Safety, covering Safety Writing & Aggregate Reports, Benefit-Risk Assessment & Safety Evaluation, Risk Management Plans & REMS.
Capabilities in this workflow
Vendors supporting this workflow
Products: LifeSphere, NavaX +4 more
“Achieve next-generation patient safety using a powerful safety analytics engine that enables safety teams to conduct faster, more robust benefit-risk analyses.”Source: arisglobal.com
Also offers: Safety Database Platforms, PV Automation & AI Case Intake, +3 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Our highly qualified Pharmacovigilance experts produce periodic aggregate reports in both the ICH formats (such as DSURs, PSURs, PBRERs) and non-ICH formats (such as U.S. PADERs…”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
CRO / Research Services Provider · +1 more type
“We also prepare Periodic Safety Update Reports (PSURs) and support risk management plan development and implementation as required by COFEPRIS post-approval conditions…”Source: althian.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more
Service Provider · +2 more types
Products: D.AI.M.I.
“PLG supports our clients through the following types of reports covering large regulatory landscape (EU, UK, USA, Australia, Canada and ROW countries): DSURs- PBRERs PADERs”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
Consulting / Advisory Firm · +2 more types
“…Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs) Risk Management Plans (RMPs)…”Source: voisinconsulting.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“We deliver objective safety and efficacy review at critical milestones, enabling early risk identification, benefit‑risk assessment, and appropriate recommendations to protect…”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more
CRO / Research Services Provider · +5 more types
“Integrated summaries of safety/efficacy Annual and periodic safety reports”Source: frontagelab.com
Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more
Agency · +2 more types
“…Pediatric Investigation Plans (PIP)/Ped Plans (PSP) Post-authorisation Safety Study (PASS) Aggregated safety reporting Risk Management Plans (RMP)”Source: bioscriptgroup.com
Also offers: Medical Communications Writing, Regulatory Writing & Dossier Content
CRO / Research Services Provider · +2 more types
Products: ClinQuick
“IND annual reports (DSUR) and maintenance”Source: celerion.com
Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +2 more