Achieving 100% Data Quality in SEND Submissions with SEND Assure
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 is a Ruby Sponsor of CDISC India Day 2025
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...
Redesigning the Pipeline: Smarter Data for Strategic Advantage
The pharmaceutical and biotechnology industries are sitting on a paradox: while the science of biology advances at unprecedented speed, the data systems designed to capture and interpret that science remain stuck in outdated, transactional architectures. This isn’t just a technical mismatch, it’s a strategic liability. One that affects not only sponsors, but regulators and the...
Shivakumar Swamy Joins PointCross as Head of Quality & Compliance
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...
Aruna Adhikari Thapa Joins PointCross
We’re excited to welcome Aruna Adhikari Thapa as our new Chief Product & Commercial Officer at PointCross Life Sciences. Aruna brings 20+ years of experience leading product and commercial strategy across diverse technology verticals including health tech. From scaling platforms at IQVIA and DrugDev to being named one of PharmaVOICE’s 100 most inspiring leaders in...
PointCross Sponsors PHUSE SDE Hyderabad 2025
Date: Saturday, 21 June 2025Location: Hyderabad, India PointCross Life Sciences was proud to sponsor the PHUSE Single Day Event (SDE) in Hyderabad. The event brought together data science and regulatory professionals from across the life sciences industry, offering a platform to exchange ideas and drive innovation in clinical and non-clinical analytics. Featured Presentation Libin Varghese, Principal Solutions...
Webinar: Ensuring 100% Submission Data Quality with SEND ASSURE
Date: Wednesday, May 28, 2025 Time: 9:00 AM PT | 12:00 PM ET Most SEND preparers (CROs, Vendors, In-house) perform spot-checks, visual QC, or checklist based compliance to ensure their SEND datasets are submission ready and compliant with the FDA's Technical Conformance Guide and Technical Rejection Criteria. Learn how PointCross uses automation, reconciliation checks, and 100% traceability...
Webinar- Automating Biomarker Standardization: Highlighting best practices for the Cell Phenotyping (CP) domain
Webinar Overview: Date: Wednesday, April 23rd, 2025Time: 09:00 AM PT Biomarker standardization is crucial for regulatory-compliant clinical trials and drug development. This webinar will explore how intelligent automation enhances biomarker data quality, streamlines regulatory submission, and improves patient outcomes. Key Takeaways:• Standardizing biomarker data for compliant submissions• Automating cell phenotype characterization using marker expression• Addressing standardization challenges...
PointCross at PHUSE APAC SDE 2025
PointCross Life Sciences participated in PHUSE APAC SDE 2025, hosted by Hexaware Technologies, where industry experts convened to discuss Emerging Therapeutic Technologies, Precision Medicine, and Biomarker Data. Dr. Sapna Chandran (PointCross Life Sciences) and Mohit Sehgal, Ph.D. (Hexaware Technologies) contributed valuable insights on the role of automation, AI/ML, and regulatory-compliant data management in clinical...
PHUSE US Connect 2025
Date: March 16-19, 2025Location: Orlando, Florida PointCross Life Sciences participated in PHUSE US Connect 2025 in Orlando, where Harinarayan Gopichandran presented his paper, “SD03: Turbocharge Your Trials: Transform CRF Creation and the CDISC Standardization Process with Smart Metadata Repositories and AI/ML Innovations.” Key highlights included demonstrating how our MDR:• Enhances data standardization for SDTM and ADaM...
SOT 64th Annual Meeting
Date: March 16-20, 2025 Location: Orlando, Florida The SOT 64th Annual Meeting and ToxExpo, held from March 16-20, 2025, at the Orange County Convention Center, Orlando, FL, successfully brought together leading experts in toxicology. The event featured scientific sessions, poster presentations, and networking opportunities, along with the three-day ToxExpo showcasing the latest advancements in the field. Thank...
Bay Area Biotech-Pharma Statistics Workshop (BBSW)
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...
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,...
Hexaware Launches Clinical Data Automation as a Solution (CDaaS) in Partnership with PointCross Life Sciences
Iselin, NJ –– Hexaware Technologies, a global provider of IT services and solutions serving X of top 20 leading pharmaceutical sponsor companies, and PointCross Life Sciences, today announced a partnership to introduce Clinical Data Automation as a Solution (CDaaS) powered by PointCross’ Xbiom™ platform. This solution is designed to enhance the clinical data lifecycle,...
Unlocking Insights: Cross-Study Analysis of SEND Datasets with Xbiom™
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...
Webinar on Visualization of SEND datasets
Date: Wednesday, July 31st, 2024Time: 09:00 AM PT / 12:00 PM ET PointCross Life Sciences held a webinar on Visualizing your SEND datasets. What we covered: How to visualize SEND datasets for QC Conducting in-depth subject-level reviews Mastering cross-study comparison and analysis Understanding the limitations of using only SEND datasets for visualizations Exploring pre-templated and customized TFLs This session is tailored for professionals in...
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...
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...
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!...
SOT ToxExpo 2024
PointCross was present at the 2024 SOT #ToxExpo. Date: March 10–14, 2024 Salt Palace Convention Center in downtown Salt Lake City, Utah Takeaways: CROs and Sponsors love PointCross’ instant SEND quote generator, fast turnaround time, and study data visualization offering Integrating bioanalytical and complex biomarker data with as collected in-life data can be done in real time and people loved seeing subject level study details for ongoing...