• QED offers experienced and comprehensive Clinical Data Management services for Preclinical as well as Phase I-IV clinical trials across many therapeutic areas.
• Our CDM staff can accomplish unique project requirements effortlessly by using our cutting-edge data management systems; SAS PheedIt (21 CFR Part 11 compliant, used for capturing and validating data for EDC). Our flexibility in accommodating changes to project specifications is accompanied with a complete audit trail while maintaining quality of study data.

 

 

The following is a summary of our Data Management services and procedures:

• Data Management Plan
• Database Design
• Data Validation
• Data Entry
• SAE Reconciliation
• Medical Coding
• Query Management
• User Support / Helpdesk
• Central Lab Database Imports
• Database Lock and Audit

Transfer of database is done in Sponsor defined formats (ASCII, SAS, and XML) and can be made as per CDISC/SDTM specifications, using SAS- Clinical DI, with detailed documentation. Data transfer error rate is least as, using PheedIt, the data is directly stored in SAS format.

Our QC process involves control checking the scientific integrity of the database by ensuring the consistency between Protocol, SAS database and CRF template and a periodic review of:

• CRF and DCF tracking and filing;
• Data entry errors and data management procedures; and
• Data entry vs. original paper CRFs.

 

 

Biostatistics
SAS Programming
Data Conversion to CDISC