For those who couldn't join us live, we're excited to share the recording of our third SEND webinar! This session focused on Cross-Study Analysis of SEND Datasets using Xbiomâ„¢, where we covered everything from building a solid study repository to comparing datasets from similar compounds and classes. During this webinar session, you will learn: Why you...
Table of ContentsThe Importance of Metadata Management Repository in Clinical Research Xbiom: A Comprehensive Solution Centralized Metadata Repository Scalability and Flexibility Enhanced Data Integration Regulatory Compliance User-Friendly Interface Advanced Analytics and Reporting Security and Access Control Xbiom Functional Components: Enhancing Metadata Management Repository 1. Metadata Repository 2. Centralized Data Repository 3. Regulatory Workflow In the fast-paced world of clinical research, managing metadata effectively is crucial. That’s where...
In this webinar, we discussed how SEND-ASSURE ensures consistency with the audited Study Report, conformance to Technical Rejection Criteria guidelines, and follows details of the Technical Conformance Guide as the trusted references for data submission and regulatory compliance. Key Takeaways: The most common errors in SEND with recommendations to correct them Feedback related to submission and analysis Pinpoint QC ideas Submit...
We're thrilled to share that our team members, Raja and Arpitha, recently had the privilege to attend Verisian's first community event in Hyderabad. During the event, we had the opportunity to present on: "Leveraging LLMs for Traceable Metadata Specifications and Executable Search Expressions in TFL & ADaM Generation." For those who couldn't make it, fret not!...
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 Xbiomâ„¢ Insights, a cutting-edge interim nonclinical study...
Introduction to Clinical Interim Study Monitoring Clinical Interim Study Monitoring has taken a giant leap forward with PointCross Life Sciences' innovative solution, Xbiomâ„¢ 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,...