DSG is fully compliant with 21 CFR Part 11 and follows CDISC standards
21 CFR Part 11 applies when using a computer system to create, modify, transfer or store an electronic representation of any information or process that is regulated by the Food and Drug Administration (FDA). Our interpretation of 21 CFR Part 11 is conservative and expansive.
DSG is fully compliant with 21 CFR Part 11, and employs personnel responsible for managing the dynamic nature of these regulations. DSG has met the 21 CFR Part 11 requirements according to multiple auditing teams deployed by top pharmaceutical companies and contract research organizations with expertise in the system validation and compliance area.
DSG’s eCaseLink EDC fully integrates with all types of vendors including Central Laboratories, eDiaries/ePRO, Specialty Laboratories, IVRS, CTMS, ECG Providers, CT Scans & MRI providers, Topographies & Radio-graphics providers, Safety systems, EMR, and Medical Device Output. eCaseLink facilitates the seamless exchange of data to all systems within the clinical study, in real time.
DSG has a dedicated group of project managers and trial developers that maintain CDISC standards on all of our eClinical software applications. Although CDISC standards are currently not required on submissions to the FDA, DSG continues to promote the use of these standards and provides consulting to our clients whenever necessary to ensure compliance.