Our clinical data management team is using the advanced and comprehensive clinical data management CDISC ODM standards-compliant software to ensure auditable GCP quality results.
Our data management services include:
- Paper-based and web-based trials
- Electronic Data Capture in full compliance with CFR 21 part 11
- Blind and independent double data entry
- Full electronic Audit Trail
- Computer-generated and fully tracked Data Clarification Forms (queries)
- Coding terms using MedDRA, WHO adverse events and medications, or client’s custom dictionary
- Automated and manual capabilities for import, export, and interchange of clinical data with other systems
- Archival to CD-ROM and PDF
- Reconciliation of safety database vs. study database
Paper-based process:
Paper-based process implies independent double data entry with a third party referee. Data is collected on paper forms and entered by two individuals, each working independently of the other, into two separate data sets. The two data sets are compared by a third person, who reconciles discrepancies. The resolved data set permanently save as a separate data set, as well as add to the data stream for that data type.
Web-based process:
Web-based process implies that data is entered directly from study sites into electronic CRFs (eCRFs). Error checking during data entry at the sites allows early detection and correction of errors including direct checking against source documents.
Both internal and external audits of our databases verify low error rates. Our clients can be assured that study data is being managed properly. It does not matter if your study requires paper, or web-based data collection, we have the experience, expertise, and tools to manage your data.
Access to online demo version of OCT CDMS is available upon request. Please contact us at info@oct-clinicaltrials.com
