From FAIR Data to FAIR Knowledge Sharing
Phuse poster jointly worked with PointCross Lifesciences and Roche
Xbiom– A Workbench for Biomarker & Translational Research
The paper presents query masks for stratifying cohorts and search analytics on clinical and biomarker data as available on the Xbiom solution
Benchmark Your SEND Readiness Whitepapers
Benchmark Your SEND Readiness
Synthetic Dataset
Synthetic Dataset for Public Use (PC201708)
SEND ASSURE™ Whitepaper
Assuring your SEND Datasets are Consistent with your Study Report...
Data Standardization Services
Receive a SEND package guaranteed to load into the FDA's Nonclinical Portal...
Data Consistency and Quality Issues in SEND Datasets
PointCross has reviewed numerous SEND datasets prepared for test submissions to the FDA and has worked with the FDA on their KickStart program to ensure that received datasets are suitable for pharm/tox review...
Importance of Data Consistency and Quality in SEND Submissions
With the recent release of the FDA’s binding guidance for electronic submission of nonclinical data, sponsor submissions will be required to include electronic datasets in SEND format in addition to the study report...
Semantic Data Exchange for Pharma R&D
Semantic Data Exchange Facilities to enable flexible support for data standards and cross-study meta analysis in the Pharmaceutical Industry...
Webinars
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...
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...
eDataValidator for SDTM, ADaM & SEND
View Webinar Recording: eDataValidator (eDV) for Validating SDTM, ADaM & SEND Click here to sign up for eDataValidator Having trouble viewing the video? Please click here Here is a brief overview of the webinar's key highlights and takeaways. In this webinar, we provided a 30-minute walkthrough of eDV, demonstrating how users can effectively validate their SDTM, ADaM or...
Interim Study Monitoring Webinar
October 19th 2021
Xbiom Smart Transformer – Demo
Rapidly map legacy and raw data to CDISC standards - View Video
SEND Dataset FRR Webinar: Tools & QC Checks
June 8th, 2020
100% Consistency Check of SEND Datasets Against NCSR
March 17th, 2020
PointCross Live Discussion – Recent Regulatory and Standards Updates
Recent FDA Regulatory and Standards UpdatesTuesday, December 11th, 2018
Integrating Clinical, Biomarker & Disparate Data
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
What does SEND Readiness mean for your company? – Webinar
Watch the replay of this webinar held on June 27: What does SEND Readiness mean for your company The FDA will soon require drug companies to transmit their nonclinical data submissions in standardized electronic formats like SEND. This will fundamentally impact workflows and data management within drug companies and CROs, and will require nonclinical toxicologists to...
Demos
PointCross Life Sciences – Get SEND Ready Today
PointCross Life Sciences' SEND solutions are designed to help the industry become SEND Ready over the next 18-24 months and support their future research needs.
Study Data Integration & Search (SDIS™) Demo
PointCross Life Sciences SDIS is the first solution of its kind that closes a major gap in the nonclinical phase of the R&D lifecycle. SDIS creates an instantly searchable resource of all nonclinical study and assay data for BioPharma companies and regulatory agencies.
Streamline Study Data Integration with SD
PointCross Life Sciences Study Data Integration and Search solution for the Biotech and Pharmaceutical industry provides a one-stop "Data-to-Insights" environment for nonclinical scientists to evaluate safety and efficacy indicators and biomarkers across normalized study data spanning internal and external sources, and global research sites.
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...
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...
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...
Conference: PhUSE SDE – Canton, MI
Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials | Tuesday 29 September 2020
PhUSE CSS 2020 Poster
PointCross presented and was awarded Best Poster In the Industry category for our poster, A Process for Automated Reconciliation of SEND Datasets with Study Reports for Confident Submission and Review.
Taking full advantage of the SEND data potential
Jointly published by Roche and PointCross Lifesciences
Visualization of “Real Time” Data from Ongoing Non-Clinical Studies in Support of Study Monitoring and informed Decision Making
PointCross will be holding a joint presentation with Roche | 9th–13th November
Face-to-Face CDISC SEND at FDA
April 1 - 5, 2019
PhUSE CSS Computational Science Symposium
March 4 – 6, 2018 | Silver Spring, MD
PointCross releases eDataValidator for SDTM, ADaM, SEND, and Define.XML conformance to prevailing FDA, CDISC, and PMDA rules
PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing demand from sponsor Clinical...
Beginning on September 15, 2021, FDA will begin enforcing the Technical Rejection Criteria (TRC).
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 ( Technical Rejection Criteria for Study Data) The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th,...
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 ( Technical Rejection Criteria for Study Data) The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th,...
PointCross Life Sciences and Xybion forge strategic partnership to deliver SEND services to assure FDA review ready submissions
XYBION AND POINTCROSS ESTABLISH A STRATEGIC PARTNERSHIP TO DELIVER SEND SERVICES TO ASSURE FDA REVIEW READY SUBMISSIONS March 11, 2016: PointCross Life Sciences and Xybion announced today a strategic partnership to provide the Biopharma industry with a complete suite of data management, standards governance, data quality assurance and regulatory review solutions to comply with the FDA’s...
PointCross & CAC EXICARE Partner for CDISC Implementation
PointCross Life Sciences and CAC EXICARE forge strategic implementation plan For pharma and biotech companies in Japan, this collaboration will ease the implementation of CDISC standards for electronic regulatory submissions which are a requirement by both the US FDA and Japanese PMDA CAC EXICARE’s Location in Tokyo Japan and PointCross Life Sciences’s Location in Foster City,...
PointCross Life Sciences: Gartner Cool Vendor 2013
PointCross Life Sciences Named to Gartner’s Cool Vendor 2013 List for Life Sciences FOSTER CITY, CA, May 15, 2013 PointCross Life Sciences announced today that it has been included in the list of “Cool Vendors in Life Sciences, 2013” ¹ by Gartner, Inc. PointCross Life Sciences is a leading provider of solutions designed to unleash the...