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...
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advances at unprecedented speed, the data systems designed to capture and interpret that science remain stuck in outdated, transactional architectures.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...
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...
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...
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 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...