Does my Study need SEND?
As a toxicologist running multiple GLP and non-GLP studies, you and your team often plan budgets, study schedules, and contracting activities with your CRO and external vendor labs. There is, often times, one critical-path topic that often appears as a line item in a Statement of Work between you and your CRO partner. That line...
PHUSE EU Connect 2025
Event Date: 16 โ 19 November 2025Location: Hamburg, Germany ๐๐ฌ ๐๐ฅ๐ข๐ง๐ข๐๐๐ฅ ๐๐๐ญ๐ ๐ ๐ซ๐จ๐ฐ๐ฌ ๐ฆ๐จ๐ซ๐ ๐๐จ๐ฆ๐ฉ๐ฅ๐๐ฑ, ๐ฆ๐๐ญ๐๐๐๐ญ๐ ๐๐๐งโ๐ญ ๐๐ ๐๐ง ๐๐๐ญ๐๐ซ๐ญ๐ก๐จ๐ฎ๐ ๐ก๐ญ.At PHUSE EU Connect 2025, Harinarayan Gopichandran, VP Technical Solutions at PointCross, demonstrated how the ๐๐๐ข๐จ๐ฆ ๐๐ฆ๐๐ซ๐ญ ๐๐๐ญ๐๐๐๐ญ๐ ๐๐๐ฉ๐จ๐ฌ๐ข๐ญ๐จ๐ซ๐ฒ (๐๐๐) helps Sponsors and CROs ๐ด๐ต๐ณ๐ฆ๐ข๐ฎ๐ญ๐ช๐ฏ๐ฆ clinical trial setup, ๐ข๐ถ๐ต๐ฐ๐ฎ๐ข๐ต๐ฆ metadata governance, and ๐ช๐ฎ๐ฑ๐ณ๐ฐ๐ท๐ฆ consistency across studies. Managing metadata through...
Refreshing Clinical Data Validation for Modern BioPharma
Validation and study data quality should be thought of as iterative and continuous workflows. Yet, many teams still work within usage models and contract terms that make it harder to validate for rules and conformance checks as often as needed. eDataValidator was designed to change that. Built by PointCross, and used for well over 100,000...
PointCross at PHUSE SDE Bengaluru 2025 – Gold Sponsor
Event Date: Saturday, 22 November 2025Location: Bengaluru, India About the Event The PHUSE Single Day Event (SDE) in Bengaluru brought together leaders across the clinical research ecosystem to discuss how emerging technologies -AI, ML, RPA, and intelligent data systems are transforming clinical data science. With the industry rapidly shifting toward automation and real-time analytics, the event...
Metadata Repository: Your Strategic Edge in Clinical Development
Most research organizations spend 16-20 weeks setting up each clinical trial. Six of those weeks go to creating SDTM datasets alone. This isn't just slow. It's expensive, risky, and getting worse as regulatory requirements grow more complex. The problem isn't the work itself. It's how we manage the metadata that gives meaning to clinical data What...
Bridging the Gap: How Natural Language AI Can Transform Clinical Data Access
As the BioPharma industry evolves toward more data-intensive, portfolio-wide agile decision-making, under pressure to innovate and reduce the time to market, organizations that master bridging the questions of their staff to regulatory compliant, verifiable responses retrieved from their study data systems will move faster, decide smarter, and ultimately bring therapies to patients more efficiently,...
Ask with Ease. Retrieve with Rigor. Study Data Secured by RAG-Enabled Chat in Xbiom
The biopharmaceutical industry is entering a new era where the ability to harness data directly determines the speed and success of drug development. Clinical trials, nonclinical studies, and biomarker assays now generate massive volumes of complex data. When unified and made accessible, clinical trial data accelerates insights, strengthens regulatory confidence, and reduces development risk. PointCross enables...
How Leaders Can Shape Drug Success Through Data
The Case for Faster, Smoother Approvals Every day saved in the approval process matters. Faster reviews mean therapies reach patients sooner, investors see value earlier, and science delivers its impact without avoidable setbacks. The encouraging news is that most delays are not because science failed. They happen because submissions were not fully supported by strong data...
The Hidden Bottleneck Undermining Pharma’s Mission
Every pharma executive faces the same core challenge: developing safe, efficacious therapies that reach patients while delivering sustainable returns. The industry exists for one fundamental purpose: to discover, develop, and deliver innovative treatments that are both clinically proven and commercially viable. Yet despite record R&D investments, most companies are trapped in cycles that work against...
The AI Revolution CMOs & CSOs Need Now
Modern pharmaceutical companies take a different path on their journey into the digital age. CMOs and CSOs must have a say. If youโre a Chief Medical Officer, Chief Scientific Officer or Clinical Development leader, you know the frustration all too well: your teams are wrangling data from multiple sources, electronic data capture systems, labs, patient-reported...
Enterprise LLMs for BioPharma Therapeutics Developmentย
Abstract Large Language Models (LLMs) have the potential to significantly accelerate therapeutics development while reducing costs and increasing innovation in the biopharmaceutical industry. However, two critical barriers prevent widespread adoption of this technology. First, competitive sensitivities and data sovereignty requirements mandate that clinical trial and nonclinical study data remain within pharmaceutical companies' secure networks. This necessitates...
PointCross at PHUSE SDE 2025 โ South San Francisco
Date: Friday, 22 August 2025Location: Genentech, 350 DNA Way, South San Francisco, CA 94080 Event Theme: Revolutionising Healthcare: The Transformative Power of Data Analytics and AI The PHUSE SDE 2025 brought together experts from healthcare, technology, and regulatory sectors to explore how advanced analytics, machine learning, and predictive modelling are transforming healthcare and drug development. Discussions...
Breaking Free from Clinical Data Chaos: The AI Revolution CMOs & CSOs Need Now
How modern pharmaceutical companies can finally catch up with the digital age If you're a Chief Medical Officer, Chief Scientific Officer or Clinical Development leader, you know the frustration all too well. Your teams are drowning in data from multiple sources, electronic data capture systems, labs, patient-reported outcomes, and real-world evidence, but somehow, getting actionable...
Bridge Over Troubled Data: How RAG Connects AI Dreams to BioPharma Reality
In the troubled waters of modern drug development, where clinical insights are scattered across countless studies and siloed systems, researchers are searching for something that can safely carry them from fragmented data to unified intelligence, simply. They need a bridge. AI promises to deliver the solutions to the problems that a historically averse to rapid...
Achieving 100% Data Quality in SEND Submissions with SEND Assureย
Ensuring the quality of data submitted to regulatory agencies like the FDA (CBER and CDER) is vital in the Life Sciencesย 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 isnโt just a technical mismatch, itโs a strategic liability. One that affects not only sponsors, but regulators and the...
Shivakumar Swamy Joins PointCross as Head of Quality & Compliance
Weโre 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
Weโre excited to welcome Aruna Adhikari Thapa as our new Chief Product & Commercial Officer at PointCross Life Sciences.ย 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 PharmaVOICEโs 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...