Electronic Common Technical Document (eCTD)

The National Institute of Health (NIH) intends to award a sole source purchase order for the National Institutes of Allergy and Infectious Diseases (NIAID) to acquire Electronic Common Technical Document (eCTD) services. The purpose of this acquisition is to maintain regulatory compliance, ensure adherence to current industry standards, and minimize security vulnerabilities. The services include providing Institutes and Centers (ICs) and Clinical Research Organizations (CROs) with the ability to support the assembly and management of eCTD packages, compilation, publishing, validation, and review of FDA mandated regulatory submissions, and providing a secure document repository for the storage of Sponsor documents with role-based access controls. • Provides Institutes and Centers (ICs) and Clinical Research Organizations (CROs) with the ability to support the assembly and management of eCTD packages • Allows compilation, publishing, validation, and review of FDA mandated regulatory submissions • Provides CROs with access to the System functionality from outside NIH Intranet • Provides a secure document repository for the storage of Sponsor documents with role-based access controls • Ensures integration of the secure document repository with the eCTD compilation and publishing tool