Expedited Safety Reporting & Regulatory Submissions Vendors
Compare services that prepare, track and submit expedited individual safety reports to regulators, ethics committees, investigators and partners.
Related workflows
Products: LifeSphere, NavaX +4 more
“Document Distribution simplifies your global drug safety and safety reporting operations by making it quick and easy to distribute safety reports to key stakeholder groups.”Source: arisglobal.com
Also offers: Safety Database Platforms, PV Automation & AI Case Intake, +3 more
CRO / Research Services Provider · +1 more type
“We manage this process end to end, ensuring no deadline is missed and every report meets regulatory requirements. We also prepare and submit Individual Case Safety Reports (ICSRs)…”Source: althian.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Veristat provides global submission of SUSARs to regulatory agencies as part of its clinical trial safety services.”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
“Automate global health authority submissions with built-in gateway and reporting rules.”Source: veeva.com
Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more
Service Provider · +2 more types
Products: D.AI.M.I.
“ICSR submission to EVWEB / MHRA / USFDA”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
Consulting / Advisory Firm · +2 more types
“Expedited Safety Reporting: Most of the regulations that describe safety reporting from clinical trials focus on the expedited reporting of individual case safety reports (ICSRs)…”Source: voisinconsulting.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more
Compare listed vendors
What this covers: Preparation, tracking, and submission of individual expedited safety reports to regulators, ethics committees, investigators, partners, or other required recipients.
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Althian Clinical Research | CRO / Research Services Provider | ICSR Case Processing, Safety Medical Review | “…Expedited Safety Reporting+ Unexpected serious adverse reactions require expedited reporting to health authorities within defined timeframes — 7 days for…”althian.com · reviewed Oct 24, 2026 |
| ArisGlobal | Software / Technology Platform | Adverse Event Intake & Triage | “Document Distribution simplifies your global drug safety and safety reporting operations by making it quick and easy to distribute safety reports to key…”arisglobal.com · reviewed Oct 26, 2026 |
| ProductLife Group | Service Provider | Adverse Event Intake & Triage, ICSR Case Processing, Safety Medical Review, Medical Information & PV Intake Services | “ICSR submission to EVWEB / MHRA / USFDA”plglifesciences.com · reviewed Oct 26, 2026 |
| Veeva Systems | Software / Technology Platform | Adverse Event Intake & Triage | “Automate global health authority submissions with built-in gateway and reporting rules.”veeva.com · reviewed Oct 19, 2026 |
| Veristat | CRO / Research Services Provider | Adverse Event Intake & Triage, ICSR Case Processing, Safety Medical Review, Medical Information & PV Intake Services | “Veristat provides global submission of SUSARs to regulatory agencies as part of its clinical trial safety services.”veristat.com · reviewed Oct 21, 2026 |
| Voisin Consulting Life Sciences | Consulting / Advisory Firm | Adverse Event Intake & Triage, ICSR Case Processing | “Expedited Safety Reporting: Most of the regulations that describe safety reporting from clinical trials focus on the expedited reporting of individual case…”voisinconsulting.com · reviewed Oct 20, 2026 |