In the past, sponsors submitting to FDA were required to submit a PDF describing their submission datasets. As we all know PDF is great for viewing on-screen or printing, but the information inside ...

Define-XML is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s needed to help reviewers understand the data they are reviewing.

独立行政法人情報処理推進機構（IPA）および一般社団法人JPCERT コーディネーションセンター（JPCERT/CC）は2月14日、tsClinical ...

Ever felt bogged down by paperwork in your quest to move medical science forward? Clinical research, the engine of medical progress, can get stuck in a rut of cumbersome data analysis, data collection ...