Clinflash Safety

About UsSolutionsContact UsPartners
English
简体中文English繁體中文日本語
Pharmacovigilance Safety Database
Clinflash Safety
Helping simplify drug and device safety management with powerful analytics and reporting capabilities
Compliant, high-quality and efficient safety databaseClinflash Safety complies with the updated pharmacovigilance regulations and standards at home and abroad, and supports E2B R3 standards. It can be connected to regulatory agencies through Gateway or XML to efficiently complete the whole process of handling, reporting and analyzing adverse events, flexibly applied to the safety management of chemical drugs, biologics, vaccines, and medical devices in the clinical and post-marketing stages
01ComplianceMeet the pharmacovigilance regulations21CFR Part 11 (System Core Specification)Meet the audit requirements with full operational traceability
02High qualityComprehensive supporting servicesE2B calibration, logical verification of dataDevelopment in accordance with GAMP5 (System Validation Standard)
03High efficiencyUser-friendly interface and quick to launchSupport batch processing of reportsOne-click report generation, one-click submission
01
ComplianceMeet the pharmacovigilance regulations21CFR Part 11 (System Core Specification)Meet the audit requirements with full operational traceability
02
High qualityComprehensive supporting servicesE2B calibration, logical verification of dataDevelopment in accordance with GAMP5 (System Validation Standard)
03
High efficiencyUser-friendly interface and quick to launchSupport batch processing of reportsOne-click report generation, one-click submission
Powerful features to enhance pharmacovigilance efficiency
01Signal detection

signal detection, signal verification, signal evaluation, report download, aggregation signal
03Periodic report management

Online editing and management of periodic reports (DSUR, PSUR, PBRER, etc.), PSMF, RMP
05Global submission

Support for electronic submission of CDE, CDR, FDA, EMA, MFDS and other safety reports
07Literature retrieval

Literature task configuration, automatic retrieval, literature report management
02Individual case report management

Individual case report management for drugs, devices and vaccines before and after market launch, with automatic generation of reports in multiple formats; anticipatory auto-determination, embedded IME list, and multi-language support
04Clinnical site submission

Support SUSAR report submission to investigators, institutions, ethics committee/IRB, with flexible configuration of submission rules and follow up through WeChat mini programs
06Flexible reporting

Multi-dimensional data filtering, flexible report export, free export of analysis charts. Case statistics, progress management, and overdue warning
08Data import

Support for a variety of import methods: XML, feedback data, fully integrated with Clinflash EDC, improving entry efficiency
111
Powerful features to enhance pharmacovigilance efficiency
Signal detectionsignal detection, signal verification, signal evaluation, report download, aggregation signal01
Individual case report managementIndividual case report management for drugs, devices and vaccines before and after market launch, with automatic generation of reports in multiple formats; anticipatory auto-determination, embedded IME list, and multi-language support02
Periodic report managementOnline editing and management of periodic reports (DSUR, PSUR, PBRER, etc.), PSMF, RMP03
Clinnical site submissionSupport SUSAR report submission to investigators, institutions, ethics committee/IRB, with flexible configuration of submission rules and follow up through WeChat mini programs04
Global submissionSupport for electronic submission of CDE, CDR, FDA, EMA, MFDS and other safety reports05
Flexible reportingMulti-dimensional data filtering, flexible report export, free export of analysis charts. Case statistics, progress management, and overdue warning06
Literature retrievalLiterature task configuration, automatic retrieval, literature report management07
Data importSupport for a variety of import methods: XML, feedback data, fully integrated with Clinflash EDC, improving entry efficiency08
Multi-channel data reception and processingwith one-click global electronic submission of Individual Case Safety Report (ICSR)
Multi-channel data reception and processingwith one-click global electronic submission of Individual Case Safety Report (ICSR)
Diverse data export options
Flexible export of multiple reports and quick launch
Quick submission of SAE reports, CIOMS, E2B XML, MedWatch, upon finishing the regulatory report
Support the holder’s ADR report export, one-click direct reporting of ADR on the Safety system, to meet the needs of fast MAH direct reporting of adverse reactions
CIOMS
Support blind and non-blind export of CIOMS in Chinese and English
SAE Form
Submission of serious adverse event reports to the Registration Division, EC, etc
MedWatch
Latest version of MedWatch statement for submission of FDA IND Safety Report
XML
Support E2B R2/R3 XML export in Chinese and English
Device reports
Clinical trial SAE/device defect reports, registrant medical device adverse event reports
MAH reports
MAH adverse reaction reports, one-click direct ADR reports
Diverse data export options
1.Flexible export of multiple reports and quick launch
2.Quick submission of SAE reports, CIOMS, E2B XML, MedWatch, upon finishing the regulatory report
3.Support the holder’s ADR report export, one-click direct reporting of ADR on the Safety system, to meet the needs of fast MAH direct reporting of adverse reactions
CIOMS
Support blind and non-blind export of CIOMS in Chinese and English
SAE Form
Submission of serious adverse event reports to the Registration Division, EC, etc
MedWatch
Latest version of MedWatch statement for submission of FDA IND Safety Report
XML
Support E2B R2/R3 XML export in Chinese and English
Device reports
Clinical trial SAE/device defect reports, registrant medical device adverse event reports
MAH reports
MAH adverse reaction reports, one-click direct ADR reports
Pharmacovigilance Services
Clinflash EDC
Clinflash IRT
The leading provider of digital solutions and professional services in field of clinical development
Company Hotline：400-803-8655
Business Cooperation：bd@clinflash.com
Technical Support：edchelp@clinflash.com
Jiaxing Office：3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRC
Shanghai Office：Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. China
Hangzhou Office：16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
About Us
About Clinflash
News
Marketing Events
Solutions
Data Acquisition Solution
DCT-Related Solutions
Registration and Pharmacovigilance Solutions
Professional Clinical Trial Services
Project Management Solutions
Contact Us
Business Contact
Technical Support
Join Us
Partners
Partners
Clinflash EDC Certified CRO
Clinflash official account
Zhejiang ICP 15024529-3Copyright © 2026 Clinflash International Limited. All Rights ReservedZhejiang Public Network Security 33040202000550Privacy PolicyService Levels (SLA)System Node Policy
``
The leading provider of digital solutions and professional services in field of clinical developmentCompany Hotline：400-803-8655Business Cooperation：bd@clinflash.comTechnical Support：edchelp@clinflash.comJiaxing Office：3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRCShanghai Office：Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. ChinaHangzhou Office：16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
Clinflash official account
Privacy PolicyService Levels (SLA)
Zhejiang ICP 15024529-3Copyright © 2026 Clinflash International Limited. All Rights ReservedZhejiang Public Network Security 33040202000550
Tip
Tip