Learn how PointCross eliminates this bottleneck with Single Track Processing - simultaneously producing compliant Study Reports and submission-ready SEND datasets from a single governed data source, delivering both in 2–3 weeks after data lock with 30–50% cost savings.
Nonclinical contract research organizations (CROs) face a structural inefficiency in the preparation of exploratory and pivotal toxicology study packages: the Study Report and its companion SEND (Standard for Exchange of Nonclinical Data) dataset are generated through two separate, sequential processes from the same underlying data. This sequential workflow adds 4-5 weeks to submission timelines,...
At PHUSE US Connect 2026 in Austin, PointCross Life Sciences’ Rahul Madhavan, alongside collaborators from Merck Group and Daiichi Sankyo, led a hosted session on “Building a Better MDR†and introduced the soft launch of an industry-first white paper. What began as an observational critique of spreadsheet-based standards management evolved into a broader vision -...
Date: March 22–26, 2026Location: San Diego, California PointCross attended the Society of Toxicology (SOT) 65th Annual Meeting and ToxExpo, held March 22–26, 2026, in San Diego, CA. The event brought together leading toxicologists, researchers, regulators, and industry professionals to share the latest scientific discoveries, technologies, and regulatory advancements in toxicology. At Booth #2107, the PointCross team...
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...
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...
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...
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...
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...
Date: Wednesday, May 28, 2025 Time: 9:00 AM PT | 12:00 PM ET https://youtu.be/lC7Qtd_YSrY?si=UXN18e5vQYdZTqa6 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...