We’re excited to announce that Shivakumar Swamy has joined PointCross Life Sciences as our Head of Quality & Compliance. Shivakumar brings over 25 years of experience, including 17+ years in the Life Sciences and Pharmaceutical industries, with deep expertise in: IT Quality Management & Regulatory Compliance Computer System Validation (CSV) GxP / 21 CFR Part 11 Compliance Quality Management...
We’re excited to announce that PointCross is sponsoring the Bay Area Biostatistics & Bioinformatics Symposium (BBSW) 2024. Date: October 24-25, 2024Location: Crowne Plaza Hotel in Foster City, CA This year’s symposium brings together brilliant minds to explore the future of biostatistics and bioinformatics, with keynote speakers: Dr. Gregory Alexander from the FDA Dr. Robert Tibshirani from Stanford University Learn...
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,...
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 Xbiom™, 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 Xbiom™ 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, 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...