Ensuring the quality of data submitted to regulatory agencies like the FDA (CBER and CDER) is vital in the Life Sciences industry. For nonclinical studies, the standard format is SEND (Standard for the Exchange of Nonclinical Data). SEND provides a standardized structure for submitting data, and adherence to its implementation guides (like IG 3.1.1,...
PointCross Life Sciences was proud to participate in CDISC India Day 2025, hosted by Eli Lilly in Bengaluru. The one-day event brought together global CDISC leadership, regulatory experts, and life sciences professionals to discuss the latest trends and innovations in data standardization. Our team had the opportunity to engage with industry peers and contribute to...
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...