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 you’re 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 Development
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 – 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 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...