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Author - Kavan Palangappa

PointCross Testing

Streamline Clinical Data Management Across Collection, Exchange, Analysis & Reporting with Xbiom™ MDR

The Xbiom MDR (Metadata Repository) from PointCross Life Sciences is a solution to simplify the management of global standards, therapeutic area-specific needs, and indication-specific rules for data Collection, Exchange, Analysis, and Reporting. Xbiom™ MDR is configured with: Foundational Metadata and Ontology platform functions, including: Role-Based User Management, authentication, authorization, security, permissioning, user access and workflow delegations of authority Ontology, taxonomy,...

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Clinical Research Metadata Management Repository : The Role of Xbiom by PointCross 

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...

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Webinar on The Most Common Issues in Preparing SEND: Explained

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...

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PointCross attends Verisian first community event in Hyderabad

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!...

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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...

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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....

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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...

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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...

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