PointCross Incorporates PMDA Validation Rules V4
On February 28th, 2023, PMDA released a new validation rule version 4.0 for SDTM (Study Data Tabulation Model) and Define.XML. A major change in PMDA Validator Rules v4.0 is the support of SDTM IG v3.3, as well as the removal of support...
SDTM Automation: Streamlining Clinical Trial Data
Clinical trial data management is a complex process that requires the collection and analysis of vast amounts of data. To ensure data consistency, accuracy, and integrity, the pharmaceutical industry has developed the Standard Data Tabulation Model (SDTM). In this article,...
EDC Raw Data to SDTM Curation, Mapping and Automation with the Xbiom Tool
At PHUSE US Connect 2023, PointCross Life Sciences presented a new way to automate the mapping of raw clinical EDC and non-EDC (biomarker) data to SDTM mapping through a Universal Data Model (UDM). Reducing the time to SDTM from weeks to...
Webinar on Harmonizing Raw Data with CDISC Standards to Streamline SDTMs
Date: Thursday, January 19, 2023 Time: 09:00am PT / 12:00pm ET
FDA SEND Dataset Services
Ensuring FDA Compliance with SEND Dataset Requirements: PointCross’s Comprehensive Solutions The U.S. Food and Drug Administration (FDA) requires SEND (Standard for Exchange of Nonclinical Data) as a standard for nonclinical study data submission to the Center for Drug Evaluation and...
SDTM – Everything that you need to know
What is SDTM? SDTM (Study Data Tabulation Model) is one of the requirements for data submission to the FDA (U.S) and PMDA (Japan). To facilitate data collection, management, analysis, and reporting procedures, SDTM offers a standard for organizing and presenting...
