NonClinical Articles

PointCross Testing

Webinar: Ensuring 100% Submission Data Quality with SEND ASSURE

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...

SOT 64th Annual Meeting

Date: March 16-20, 2025 Location: Orlando, Florida The SOT 64th Annual Meeting and ToxExpo, held from March 16-20, 2025, at the Orange County Convention Center, Orlando, FL, successfully brought together leading experts in toxicology. The event featured scientific sessions, poster presentations, and networking opportunities, along with the three-day ToxExpo showcasing the latest advancements in the field. Thank...

Unlocking Insights: Cross-Study Analysis of SEND Datasets with Xbiom™

For those who couldn't join us live, we're excited to share the recording of our third SEND webinar! This session focused on Cross-Study Analysis of SEND Datasets using Xbiom™, where we covered everything from building a solid study repository to comparing datasets from similar compounds and classes. During this webinar session, you will learn: Why you...

Webinar on Visualization of SEND datasets

Date: Wednesday, July 31st, 2024Time: 09:00 AM PT / 12:00 PM ET PointCross Life Sciences held a webinar on Visualizing your SEND datasets. What we covered: How to visualize SEND datasets for QC Conducting in-depth subject-level reviews Mastering cross-study comparison and analysis Understanding the limitations of using only SEND datasets for visualizations Exploring pre-templated and customized TFLs This session is tailored for professionals in...

Webinar on The Most Common Issues in Preparing SEND: Explained

In this webinar, we discussed how SEND-ASSURE ensures consistency with the audited Study Report, conformance to Technical Rejection Criteria guidelines, and follows details of the Technical Conformance Guide as the trusted references for data submission and regulatory compliance. Key Takeaways: The most common errors in SEND with recommendations to correct them Feedback related to submission and analysis Pinpoint QC ideas Submit...

SOT ToxExpo 2024

PointCross was present at the 2024 SOT #ToxExpo. Date: March 10–14, 2024 Salt Palace Convention Center in downtown Salt Lake City, Utah Takeaways: CROs and Sponsors love PointCross’ instant SEND quote generator, fast turnaround time, and study data visualization offering Integrating bioanalytical and complex biomarker data with as collected in-life data can be done in real time and people loved seeing subject level study details for ongoing...

Interim Nonclinical Study Monitoring with Xbiom™ Insights

In nonclinical studies, waiting until the completion of a study to make data-driven decisions may limit the potential for valuable insights. Traditional study reports published post-completion often lack the ability to provide on-study analysis and early indicators crucial for driving amendments and gaining deeper insights. Here comes Xbiom™ Insights, a cutting-edge interim nonclinical study...

PHUSE US CONNECT 2024: PointCross Highlights Rapid SDTM and Compliance Dashboards

PointCross Life Sciences was thrilled by the level of interest and excitement with regards to the poster we presented at PhUSE Connect 2024, titled “Rapid SDTM and Compliance Dashboards”. We had some important dialogue with industry peers and leaders in the space pertaining to revolutionizing SDTM development in clinical research. Key Takeaways: Integration of Standards and...

From FAIR Data to FAIR Knowledge Sharing

Phuse poster jointly worked with PointCross Lifesciences and Roche

Validation for Clinical SDTM, ADaM, and Nonclinical SEND Data

Introduction In the fast-paced world of life sciences validation software, accurate and compliant data validation is crucial for successful clinical and nonclinical study submissions. Ensuring the integrity of Clinical SDTM, ADaM datasets, and Nonclinical SEND data is no easy task, considering the complexity and vastness of datasets involved. In this blog, we introduce you...

NON CLINICAL

PointCross Testing