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Check out some of our latest blog posts:
July 2025
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
We are proud to announce that PointCross Life Sciences is a Ruby Sponsor of the upcoming CDISC India Day, taking place on 19 July 2025 in Bengaluru, Karnataka, hosted by Eli Lilly. This one-day event brings together global CDISC leaders, subject matter experts, and industry peers to explore the latest innovations and developments in CDISC...
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advances at unprecedented speed, the data systems designed to capture and interpret that science remain stuck in outdated, transactional architectures.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...
June 2025
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...
May 2025
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...
April 2025
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...