Quality Data Services, Inc.

Safety Management

Customized safety services with world-wide capabilities specializing in real-time decision making

Safety Management

Safety Management

A Serious Adverse Event (SAE) Data-Capture system is critical for any project. With our Safety Management System, safety data is at your finger tips and is maintained in a tightly controlled, monitored database. Your data will be available for safety personnel to review at any time, world-wide. The system itself is rol- based and allows each client to customize their process flow whether you want the QDS Safety Team or your own to interact with sites and regulatory authorities for the collection and reporting of SAEs.

Safety Managers

Our Safety Team is comprised of nurses and physicians with years of clinic and industry related experience. The team uses the Safety Management component to manage all of your safety information needs. Our experienced staff is dedicated to collecting initial information, and all required follow-up information, for complete safety services, while their responsive nature allows for real time-decisions.

Safety Services:

  • Coding of Adverse Events (AEs), Medications and Medical History in MeDRA, WHOART, Costart, NCI, and WHODrug,, as requested by client
  • Auto-generation of MedWatch and CIOMS reports
  • Narratives
  • Integrated Summary of Safety Review for signal detection

Medical Monitoring Services:

  • Pre-Screen Subject Eligibility
  • Review of Clinical Laboratory Data
  • Review and Follow-Up of SAEs
  • Review of Concomitant Medications, AEs and Medical Coding

Process

Safety Management Process