(1) Vendor needs to provide medical coding software subscription service– The Agency is seeking a Research Medical Coding Software subscription, software license and support for multiple users, Dictionary Load and related software training. The software and associated support is critical to patient safety and reporting requirements. It allows coding against the standard, accepted, medical and medication dictionaries. Medical coding facilitates timely and verifiable data collation, allowing for the creation of reports that are used in data monitoring committees, regulatory submissions, Clinical Trial.gov data uploads, and more. The Software shall be certified within the WHO Drug Software Certification for handling B3/C3 format data. The software shall have the ability to use multiple dictionaries including MedDRA and WHO Drug. Must have a study specific version control so can update study specific forms without losing previous coding. Must have a static primary key identified for each dataset. Multiple users and roles, and multiple studies. Auto and manual coding. Coding workflow allowing custom statuses to be created. Multi-step verification process. Synonym list management. Query and comment management. Custom search support.