01
01
A Trusted and Globally Compliant Safety Database Software.
Solutions for Drugs, Devices, Vaccines,
Combination Products, Veterinary and Human in pharmacovigilance. Enhance safety with advanced automation and compliance at every step.
Effortless case processing
We understand there are unique challenges you may face during the PV process. PvEdge® Automation tackles these challenges by ensuring tasks are completed promptly, allowing your team to focus on other critical priorities and drive innovation in pharmacovigilance.
Intake/ Triage
MICC
Literature
Regulatory
Web Intake
Multi Source Inbox
C
A
S
E
W
O
R
K
F
L
O
W
Case Processing
MedDRA Auto Update
Patient Narrative
QC Checklist
XML Validator
Labelling & Casualty Matrix
R2 XML
R3XML
CIOMS
Medwatch
VAERS
MDAERF
A
S
2
G
a
t
e
w
a
y
Submissions
FDA
MHRA
EMA
PMDA
TGA
KFDA
Quality process, Doc Management, Training Management
Safety Data Exchange Agreement
Report Automation PSUR / PADER / eTDC publishing
Risk Management Plans
Proporational Reporting Ration (PRR) and Chi Square Algorithm
Features
Multivigilance
Multi-Tenant
Cloud Ready
Globally Compliant
Pre Validated
Rapid Implementation
AI-Enable
Return on Investment
Impact
0
k+
Case Processed Yearly
0
k+
Legacy Data Migrated
0
k+
ICSR's Submitted Yearly
0
+
MAH’s Served
Automate Pharmacovigilance activity to the next level.
“Enhance your pharmacovigilance process with advanced automation. Streamline operations, boost accuracy, and achieve unparalleled safety with our cutting-edge solutions.”
Our additional solutions
Clinical Research
Regulatory & Compliant
Quality
Manufacturing
Supply Chain
CRM
Want to know more about PvEdge


