Thank You PointCross

Thanks for submitting the form. A member from PointCross Life Sciences will get in touch with you shortly regarding your request for a demo.

Check out some of our latest blog posts:

October 2023

Enhancing Clinical Trial Data Integrity Through Automation 

Clinical trials are an essential part of medical research and drug development. They are essential to evaluate the safety and effectiveness of new treatments and therapies. Clinical Data Management in clinical trials done in the right manner ensures the success and reliability of insights and conclusions, aiding in strategic decisions.  Data Collection and Accuracy: In...

August 2023

Validation for Clinical SDTM, ADaM, and Nonclinical SEND Data

Introduction   In the fast-paced world of life sciences validation software, accurate and compliant data validation is crucial for successful clinical and nonclinical study submissions. Ensuring the integrity of Clinical SDTM, ADaM datasets, and Nonclinical SEND data is no easy task, considering the complexity and vastness of datasets involved. In this blog, we introduce you...

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 94404 Director & the SDE Chairs: PHUSE SDE 2023 Director & the SDE Chairs PHUSE August Single Day Event (SDE) on Thursday, August 10th. This conference,...

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

eDataValidator for SDTM, ADaM & SEND

View Webinar Recording: eDataValidator (eDV) for Validating SDTM, ADaM & SEND Click here to sign up for eDataValidator Having trouble viewing the video? Please click here Here is a brief overview of the webinar's key highlights and takeaways.  In this webinar, we provided a 30-minute walkthrough of eDV, demonstrating how users can effectively validate their SDTM, ADaM or...

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 1.0 PointCross Life Sciences has incorporated the updated rulesets on April 28th, 2023....