Regulatory, Quality & SafetyPharmacovigilance & Drug Safety

Safety Intake, ICSR & Medical Review

Compare vendors for safety intake, icsr & medical review within Pharmacovigilance & Drug Safety, covering Adverse Event Intake & Triage, ICSR Case Processing, Safety Medical Review, Expedited Safety Reporting & Regulatory Submissions….

Capabilities in this workflow

Vendors supporting this workflow

ArisGlobal is a life sciences software company for drug safety, regulatory information, quality management and medical information.

Products: LifeSphere, NavaX +4 more

Evidence-backed workflow match
Matches Adverse Event Intake & Triage
“Drive immediate efficiency gains with the only solution with production-ready automation across key case intake and triage activities.”
Source: arisglobal.com

Also offers: Safety Database Platforms, PV Automation & AI Case Intake, +3 more

ProductLife Group is a life sciences consulting and outsourcing group for regulatory affairs, pharmacovigilance, quality and validation, and market access.

Products: D.AI.M.I.

Evidence-backed workflow match
Matches Adverse Event Intake & Triage
“Medical literature monitoring (EMA – MLM), national competent authority (NCA), adverse event (AE), adverse drug reaction (ADR) download/triage”
Source: plglifesciences.com

Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more

Veristat is a specialty CRO providing biostatistics, clinical data management, and regulatory strategy and writing services.

Products: InStat, CoAuthor

Evidence-backed workflow match
Matches Adverse Event Intake & Triage
“Reviewing initial and follow-up source documentation for reportability, accuracy, and completeness.”
Source: veristat.com

Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more

Althian Clinical Research is a boutique CRO supporting clinical trials, regulatory submissions, safety, data, and real-world studies in Mexico and LATAM.
Evidence-backed workflow match
Matches ICSR Case Processing
“Every SAE is reviewed medically, assessed for causality and expectedness, and processed within the timelines required by COFEPRIS and the study protocol.”
Source: althian.com

Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more

IQVIA is a CRO and technology provider delivering clinical trials, real-world evidence, commercial intelligence and safety operations.

Products: IQVIA Vigilance Platform, SmartSolve +4 more

Evidence-backed workflow match
Matches Adverse Event Intake & Triage
“Identify adverse events (AEs) and device complaints in structured and unstructured data across multiple sources”
Source: iqvia.com

Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more

Voisin Consulting Life Sciences provides regulatory, clinical, pharmacovigilance, market access and development services.
Evidence-backed workflow match
Matches Adverse Event Intake & Triage
“Case processing from intake through regulatory submission”
Source: voisinconsulting.com

Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more

Veeva Systems is a life-sciences software and data provider offering CRM, medical information, regulatory, and clinical operations platforms.

Products: Vault CRM, Veeva RIM +6 more

Evidence-backed workflow match
Matches Adverse Event Intake & Triage
“Streamline adverse event intake from emails, questionnaires, web forms, and literature articles.”
Source: veeva.com

Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more

Tika Mobile makes TikaMSL and TikaInsights for Medical Affairs teams, plus life sciences CRM, medical information, safety intake and market access tools.

Products: TikaMSL, TikaInsights

Evidence-backed workflow match
Matches Adverse Event Intake & Triage
“TikaMedInfo empowers Medical Affairs teams with AI-driven workflows to seamlessly manage requests, route adverse events, ensure compliance, and deliver the right information to…”
Source: tikamobile.com

Also offers: Life Sciences CRM, Medical Information Software Platforms, +3 more