Does my Study need SEND?
As a toxicologist running multiple GLP and non-GLP studies, you and your team often plan budgets, study schedules, and contracting activities with your CRO and external vendor labs. There is, often times, one critical-path topic that often appears as a...
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...
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...
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...
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: This session is tailored for professionals in QC, data analysis, or study management, offering hands-on tips...
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: Submit with...
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...
