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Check out some of our latest blog posts:
July 2023
PHUSE SDE 2023
Progress Towards CDISC 360 Mission with CDISC Standards, Metadata Design, SDTM/ADaM Automation and Compliance Date: Thursday 10 August 2023Location: Wind Room, Foster City Community Center, 1000 E Hillsdale Blvd, Foster City, CA 94404Registration Link: PHUSE SDE 2023 (phuse-events.org) Director & the SDE Chairs: PHUSE SDE 2023 Director & the SDE ChairsPHUSE August Single Day Event (SDE) on...
SEND Data Standardization: Streamlining Nonclinical Study Submissions for FDA Approval
Introduction Regulatory agencies like FDA require all nonclinical study data submitted for IND or NDA submissions to be in CDISC SEND format. The Clinical Data Interchange Standards Consortium (CDISC) has established a set of open data standards for the representation and exchange of standardized study data collected over the course of nonclinical and clinical studies....
June 2023
Clinical Trials: Understanding the Basics, Types, and FAQs
Clinical trials are an essential part of the drug development process, allowing researchers to evaluate the safety and effectiveness of new treatments. These trials involve testing a new medication or therapy on humans, usually in several phases, to determine its efficacy, safety, and potential side effects. In this blog post, we'll explore the basics...
May 2023
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 of Define.xml 1.0PointCross Life Sciences has incorporated the updated rulesets on April 28th, 2023....
March 2023
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, we will explore the significance of automation in clinical trials, particularly automated data mapping,...
January 2023
Clinical and Nonclinical validation Tools
When it comes to clinical and nonclinical study submission datasets to the FDA or PMDA, there are multiple validation tools available. This article will talk about eDataValidator (eDV) from PointCross Life Sciences, which offers a strong and complete validation tools for both clinical and nonclinical studies. The eDataValidator is a single solution for IND, NDA, and BLA...
FDA SEND Dataset Services
Ensuring FDA Compliance with SEND Dataset Requirements: PointCross's Comprehensive SolutionsThe 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 Research (CDER). SEND is a data standard mandate of CDISC SDTM standard for nonclinical studies...
December 2022
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 data. Implementing SDTM helps with data warehousing and aggregation, encourages mining and reuse, makes sharing...