Once a clinical trial is underway, ensuring consistent, high-quality data is essential. Because every project is unique, SGS Nutrasource's clinical data management services are implemented in a well-designed workflow tailored to your needs. This confirms compliance with regulatory guidelines while ensuring your study is completed in a timely and cost-effective manner.
Our data management team leverages SGS Nutrasource's in-house clinical trial experience to become an extension of your clinical team, from case report form (CRF) design, database specifications, creation, acceptance testing, and launch to database lock.
Globally-implemented standardizations and processes guarantee consistent, high-quality data. Our software is deployed in a controlled and secure computing environment utilizing validated software and systems (21 CFR Part 11 compliant). Data is delivered rapidly while achieving quality assurance through validation and verification procedures at every step.
Our clients benefit from:
- 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 provided in accordance with CDISC CRT-DD specification
- UAT in EDC systems
- Management of electronically transferred data (central labs, central readers)
- Reconciliation of transferred data against CRF data
- Integration of transferred data into clinical database
- Data validation
- Query generation and resolution
- SAE reconciliation
- Access to MedDRA
- Access to WHO Drug Dictionary
- Clinical database transfers (interim, final)
- SAS datasets
- SAS XPORT transport files
Learn how we can help you manage your clinical trial data with optimum quality and integrity.
Case Study: With Medrio, Nutrasource Proves the Value of Successful Data Management
Explore the advantages of data management for nutraceutical development.
Effective Data Management for Clinical Research
Verify study integrity by avoiding poorly-controlled data