SAE Management

As a web based application, the SAE Management enables clinical research investigators to have a timely, reliable and traceable tool in reporting SAE Report from clinical trials to sponsor and health authority.


The key innovative features and advantages of SAE Management are:

 

Unified SAE Management and Communication platform

  • Create and submit SAE report to regulatory authority from a unified interface
  • Track the progress of SAE report and status updates
  • PIs, sponsors, CROs and health authorities communicate within the platform
  • All the communication between the parties is traceable for inspection readiness
  • Document collaboration for sharing SAE related documents
  • Messaging services for instant communication between PIs, sponsors, CROs and health authorities

 

Highly flexible and configurable system management

  • Fully configurable and customizable Study setup functionality
  • Roles based permissions for better functional control to users
  • Single SAE data entry form for multiple regulatory submission
  • Localization settings for global acceptance
  • Can support multiple languages
  • Generate PDF versions of regulatory forms with data

 

Alerts and Signal detection

  • Receive alerts for medical emergencies on smart devices
  • Configure alerts based on the seriousness, severity and other user defined conditions of the event
  • Perform single case signal detection on DMEs, events of Interest and user defined conditions
  • Detect event product combination
  • Generate line listing and tabulation reports for signal detection

 

Quality standard and compliance driven

  • HIPAA compliance
  • 21 CRF Part 11 compliance
  • E2B(R2) compliance
  • Integration with FDA data gateway
  • Audit Trail to track changes

 

Global Data standard capability

  • MedDRA coding integration
  • WHODrug coding integration

 

Other

  • Inbuilt and ad-hoc report builder

G2 Strengths

  • US Based
  • 24/7 coverage
  • Safety expertise
  • Cost effective
  • Teamwork
  • Compliance-focused
  • Quality-driven
  • Timely turn-around
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