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Check out some of our latest blog posts:
February 2024
Interim Nonclinical Study Monitoring with Xbiom™ Insights
In nonclinical studies, waiting until the completion of a study to make data-driven decisions may limit the potential for valuable insights. Traditional study reports published post-completion often lack the ability to provide on-study analysis and early indicators crucial for driving amendments and gaining deeper insights. Here comes Xbiom™ Insights, a cutting-edge interim nonclinical study...
January 2024
Clinical Interim Study Monitoring: A Deep Dive into PointCross Xbiom™ Insights
Introduction to Clinical Interim Study Monitoring Clinical Interim Study Monitoring has taken a giant leap forward with PointCross Life Sciences' innovative solution, Xbiom™ Insights. In this blog post, we will explore the transformative capabilities of this platform, shedding light on its real-time integration of Electronic Data Capture (EDC) patient data and biomarker data from bio-samples....
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
Exchange Clinical data with SDTM, but analyze it on a Unified Repository
The BioPharma industry continues to misapply exchange standards for clinical and nonclinical data to do analysis and research. FHIR HL7 and CDISC SDTM tabulation models are perfect for accurate data “exchange” between any two computer systems that either collect, analyze or review such data. SDTM, however makes it hard to readily exploit, data within,...
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...