PointCross Blog

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...

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....

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...

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...

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....

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...

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....

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,...

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 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 Research (CDER). SEND is a data standard mandate of CDISC SDTM standard for nonclinical studies...

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...

PointCross announces full complement release of eDataValidator

July 20 2022 – PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing demand...

Benchmark your SEND Readiness

Our head of SEND Services and Chief Toxicologist at PointCross Life Sciences collaborated on a whitepaper on how to assess your SEND readiness. To access the full document, please click here. We have also summarized the document below. When we check nonclinical studies in SEND format with our SEND-ASSURE service, we find that there are significant inconsistencies...

PointCross Inks two deals for its Xbiom™ Insights – Clinical Biomarker Platform for Precision Medicine Development

FOSTER CITY, Calif., Feb. 15, 2017 (GLOBE NEWSWIRE) — PointCross Life Sciences came out of stealth mode with its Xbiom™ Insights solution for Clinical Biomarker research. With two clients deployed, PointCross is now acquiring new pharma and biotechnology companies who are pursuing precisely targeted therapies in oncology, central nervous system, and cardiovascular. Having proven...

Introducing PointCross Desktop Validator

July 20 2022 - PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing...

CIMS™: Clinical Data Repository for SDTM Data & Beyond

Clinical Data Repository for SDTM data fills an urgent gap CIMS™, the PointCross Life Science built Repository for Clinical SDTM Data is now available to Pharma sponsors with compliant standardized NDA submissions to FDA guidance. Silver Spring, MD, March 14, 2016 PointCross Life Sciences today announced its formal release of CIMS™, a Hadoop (HDFS) based extensible repository....

PointCross and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug Development

Foster City, CA, April 20, 2015 /PRNewswire/ — PointCross Life Sciences today announced a strategic partnership with InterpretOmics Pvt. Ltd. to provide an integrated Big Data and globally accessible environment for genomic interpretation and analysis of all biomarkers collected in the context of clinical trials and nonclinical studies. This platform will serve the needs...

PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions

FOSTER CITY, CA, June 6, 2013 PRNewswire PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDA’s NIMS (Nonclinical Information Management System) solution. These study data sets are not limited to the...

PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management Suite

FOSTER CITY, CA, March 12, 2012 PRNewswire The FDA has announced its intention to require Pharma companies to include nonclinical study data in standardized electronic formats as part of regulatory IND, NDA and BLA submissions. This directive is intended to help FDA reviewers better predict safety impacts of drugs in humans, and to improve regulatory...