Quality Data Services, Inc.

Data Management

Database designed with end results in mind; quality delivered

Data Management

Data Management

Data Managers

Our office based Data Managers provide full service from database development to database lock. Our Data Management services are governed by rigorous SOPs and comply with ICH, GCP, and FDA 21 CFR Part 11 regulations. Our products provide the Data Management Team a state of the art, fully compliant EDC system to conduct data review and manage queries in real time. It also ensures data accuracy and integrity with real time reporting.  Our Data Management services are tailored to fit your clinical trial needs: From individual stand-alone services to fully-functional outsourcing. 

Services from Inception to Completion:

  • Data Specifications
  • Database Development and Validation
  • Data Management Plan
  • Data Review
  • 3rd Party Vendor Data Reconciliation
  • Dictionary Coding
  • Database Closure
  • Data Transfers
  • eCRF Archival

Process

Database Go-Live Timelines

Contract Award/Project Kickoff Meeting Day 0
Final Protocol/Database Specifications Reviewed Day 1
DB Set-up Package Completed Day 1
Data Management Plan Drafted and Sent to Client Day 2
Metadata Created Day 2
Editing Groundrules Initiated Day 3
Layouts Completed/Including On-Entry Checks Day 5
eCRF Completion Manual Initiated Day 6
Release for CDM Entry Testing Day 7
Final Annotated For Entry CRF Printed/ Entry can Go-Live Day 8
Export Views Day 9
eCRF Completion Manual Completed Day 9
Editing Groundrules Completed Day 9
Edit Check Programming Initiated Day 10
Validation of Export Views Day 11
Test Plans Completed Day 11
Final Annotated CRF Printed/Test Transfer Available Day 13
Validation Completed and Documentation Compiled/ Edits can Go-Live Day 15
Ready for Client UAT/Sign-off Day 16

Data Review

  • On-Entry Validation
  • Data Issues (Pre-Monitoring)
  • mQueries (Monitor Issued)
  • eQueries (Data Management Issued)
  • Global Review
>88% reduction in queries