Clinical Data Management

Nutrasource's clinical data management services are implemented in a well-designed workflow that ensures full compliance with all applicable regulatory agency guidelines.  Our software is deployed in a controlled and secure computing environment utilizing validated software and systems (21 CFR Part 11 compliant).

Every project and every client is unique.  Nutrasource utilizes a proprietary workflow that allows us to provide services tailored to their specific needs. Our clients contract us for the data management services they need to complete their studies in a timely and cost effective manner, by leveraging our depth of experience and expertise in the conduct of clinical trials.

Globally-implemented standardizations and processes guarantee consistent, high-quality data.  Data is delivered rapidly, with quality assurance ensured by validation and verification procedures at every step of the process. Nutrasource becomes an extension of your clinical team from case report form (CRF) design and database creation to database lock.

Data Management Services:

  • Sponsor focused teams
  • Flexibility to deliver EDC or Paper with on-time quality results
  • Development of paper CDASH CRF/eCRF
  • Double-key data entry (paper CRF)
  • Data definitions are provided in accordance with CDISC CRT-DD specification
  • UAT in EDC systems
  • Management of electronically transferred data (central labs, central readers, etc)
  • Reconciliation of transferred data against CRF data
  • Integration of transferred data into clinical database
  • Data validation
  • Query generation & resolution
  • SAE reconciliation
  • MedDRA
  • WHO Drug Dictionary
  • Clinical database transfers (interim, final)
  • SAS datasets
  • SAS XPORT transport files

Clinical data management | www.nutrasource.ca

Looking for more information on clinical data management? Contact a member of our team today or email us directly at info@nutrasource.ca. You may also request a customized quote and we will contact you with details within two business days.