Standards Organizations

Standards organizations, for lack of a more poetic description, work to ensure that a wide base of adopters in an industry are on the same page. Agreed upon standards such as the Electronic Common Technical Document (eCTD), make it so that an international group of industry participants and regulatory bodies is working from one set of rules while adhering to similar expectations of quality.

The primary standards organizations in terms of eCTD submissions are the International Conference on Harmonisation (ICH), Health Level Seven (HL7) and the Clinical Data Interchange Standards Consortium (CDISC).