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....
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...
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,...
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...
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,...
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 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...
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...
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....
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,...