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,...
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...
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...
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...
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...
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...
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 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...
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...
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...