Compliance

DSG is fully compliant with 21CFR 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 satisfactorily met 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.

CDISC

DSG is the only eClinical vendor in the industry that can fully integrate all types of clinical trial data into one software application, eCaseLink. As part of this success, DSG ensures that all data that is analyzed and reported in the system follows CDISC standards and are in compliance with the four categories of data (ADaM, LAB, ODM, SDM).

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.