Smart Transformation of Disparate Biopharma Source Data to Unified Machine Readable Target Data Models
Whitepaper - June 20, 2019
Xbiomâ 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
Benchmark Your SEND Readiness
Synthetic Dataset
Synthetic Dataset for Public Use (PC201708)
SEND-ASSUREâ˘
Assuring your SEND Datasets are Consistent with your Study Report...
DSIMS⢠Software-as-a-Service
Specify, Validate, Package and Review SEND data for FDA Submissions...
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 FDAâs 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...
Steps to Comply with the FDAâs Binding Guidance on Electronic Study Data Submissions
On December 18th 2014, the FDA issued binding guidance regarding electronic submissions of nonclinical study data. This means that beginning in 2017, any organization making IND, NDA or BLA submissions...
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
Monitor and Analyze Ongoing Nonclinical Studies on Xbiomâ˘
October 19th 2021
Xbiom Workbench
Data Hub for Clinical, Translational and Biomarker Research- View Video
Xbiom Smart Transformation
Rapidly map legacy and raw data to CDISC standards - View Video
PointCross Live Discussion – Recent Regulatory and Standards Updates
Recent FDA Regulatory and Standards UpdatesTuesday, December 11th, 2018
Types of Quality issues in SEND Data Preparation
We take a look at the various types of quality issues that are seen within the industry that pertain to the data for your SEND submission. April 17th, 2018
Webinar: Quality Checking SEND Datasets
Webinar: Quality Checking SEND Datasets November 14 , 2017
How to Integrate Clinical, Biomarker, and Other Disparate Data Sources
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
SEND â A Year in Review
Title: SEND â A Year in Review Date: Thursday, December 1, 2016 Time: 1:00 PM ESTView RecordingCompanies are now familiar with the need for making SEND compliant datasets in their nonclinical submissions. However, there are still c...
Partner with PointCross to become SEND Ready and Generate New Business
Title: Partner with PointCross to become SEND Ready and Generate New Business Date: Thursday, October 29, 2015 Time: 11:00 AM ESTView RecordingJoin our business development executives to learn how you as a CRO can join forces with PointCros...
Automating CRO SEND Workflows with Sponsors
View RecordingSponsors need CROs to deliver SEND data packages in addition to the Study Reports to comply with the FDAâs e-data submission guidance that becomes mandatory for certain studies in just 14 months. Join PointCross for this inf...
Using Study Data Specifications to Integrate SEND within your Current Business Processes
Sponsors and CROs need to ensure that SEND datasets have the same level of quality and consistency as data present within the study report. To accomplish this goal, sponsors, CROs and their sub-contractors need to collaborate at all stages of study definition and execution. Attend this webinar to understand how defining and using Nonclinical Study...
Understanding the Business Impacts of SEND
The implementation of SEND will significantly impact several of your business processes. This critical aspect of regulatory operations and data management cannot simply be solved by a LIMS upgrade or by your data providers alone. Attend this webinar to learn how you can avoid risking your SEND implementation. Industry experts will describe the cross departmental...
SEND – an opportunity for CROs to Enhance Competitiveness and Business Value
This webinar will present the business opportunity of delivering high quality SEND datasets guaranteed to pass through the NIMS gateway at the FDA while bringing improved efficiency to sponsor-CRO data specifications. We will discuss how this can be done with minimal disruption to your existing business processes. On December 17, 2014 the FDA issued a...
How Test Submissions of SEND datasets to the FDA can help Sponsor companies
Description Sponsors who are planning NDA submissions from 2017 can expect to include nonclinical study data in the CDISC SEND standard to comply with the FDAâs binding guidance. In preparation for this increased flow of standardized data, the FDA encourages sponsors to make test submissions of SEND data during 2015 and early 2016 so they...
Become SEND ready quickly and cost effectively with these SaaS offerings
We will talk about our three separate SaaS offerings available under a simple subscription model, NSDS SaaSÂ â For sponsors and CROs to collaboratively develop the Study Data Specification SWP SaaSÂ â For sponsors or CROs to merge and validate data from disparate sources, and generate the SEND datasets along with the completed Define-XML and supporting documents ToxVision SaaSÂ â...
Lessons Learned from the 2015 PhUSE and SOT Conferences
View Recording The second webinar presents perspectives and insights from industry interactions at the March 2015 PhUSE/CSS and SOT conferences. This session is relevant both for people new to the SEND initiative as well as seasoned practitioners who are now realizing there is more than meets the eye when it comes to streamlining sponsor-CRO interactions...
Primer on SEND and FDA e-Data Submission Requirements
The first webinar in our series are for those who are new to the CDISC SEND standard and the FDAâs Guidance that mandates future submissions in this format. Our experts will provide an overview of the standard, and the FDAâs SEND implementation based on PointCross technology. You will hear firsthand knowledge of how e-data...
Selecting the right PointCross solution to meet your SEND related needs
Our experts will walk you through the benefits and highlights of our three SEND related offering: DSIMSfor analysis and visualization of SEND data. DSIMS is used by the FDA as their NIMS for regulatory review of your SEND datasets SEND-ASSURE for ensuring quality and consistency of your SEND datasets with the Study Report, and Data Standardization Services for packaging...
Are you confident your SEND data is ready for regulatory use by the FDA?
Join us for a Webinar to learn more As a Sponsor or a CRO, you will soon need to start preparing FDA compliant SEND datasets to the Agency. These datasets must meet consistency, quality and sufficiency criteria to support regulatory use by FDA reviewers. Whether you are just starting your SEND implementation initiative or already have...
Ensuring Data Consistency and Quality in SEND Submissions
Is there Data Consistency between your SEND Submissions and Study Reports? As a Sponsor or a CRO, you know how important it is to assure data quality in your FDA submissions. Your processes to package SEND datasets are likely being designed ensure compliance with the CDISC Standards and FDA Specific SEND Validation rules. However, will they...
Steps to Comply with FDA Guidance
Steps to Comply with FDA Guidance In December 2014, the FDA issued binding guidance for submissions of standardized nonclinical study data in SEND format. The requirement for NDA, ANDA, and certain BLA submissions compliant with FDA specifications begins on Dec 18, 2016. The requirement for INDs begins a year later. Are you ready for this major...
Learn about ambiguities in the SEND standard that need to be resolved for FDA Submission and Review Purposes
To request a copy of the webinar presentation, please contact:Â get_started@pointcross.com Abstract The FDA is already using NIMS (Nonclinical Information Management System) to receive and review submissions in standardized formats that must conform to the CDISC SEND standard and the FDAâs Nonclinical Validator Specifications. The Nonclinical Validator Specifications reflect the FDAâs implementation of the SEND standard driven...
Learn about the Benefits of Data Standardization for Completed Studies
To request a copy of the webinar presentation, please contact:Â get_started@pointcross.com Abstract The FDA is using NIMS (Nonclinical Information Management System) to perform data fitness checks and to review sponsor submissions that must conform to the Agencyâs implementation of the CDISC SEND standard. Sponsor submitted studies in PDF or non-standardized electronic formats considered to be pivotal by reviewers...
Why aggregating disparate data sources into a single âStudy Viewâ is important for your FDA e-Data Submissions
To request a copy of the webinar presentation, please contact:Â get_started@pointcross.com Abstract We discussed how consolidating all the electronic data for a âStudyâ in SEND is not simple. There are several requirements for modeling the trial design, complying with formats and terminologies, and detailed reporting on variables that are not addressed by current data collection practices and...
What are you waiting for? The FDA can review your data in ways you canât
To request a copy of the webinar presentation, please contact:Â get_started@pointcross.com Abstract The FDA is already using NIMS (Nonclinical Information Management System) to receive and review submissions in standardized formats that must conform to the CDISC SEND standard and the FDAâs Nonclinical Validator Specifications. Submitted studies considered pivotal are being standardized and loaded into NIMS for use by...
Data Standardization and DSIMS⢠Review
Join us for segment 2 of our 3 part webinar. We will discuss Data Standardization services to prepare your company now for submissions to the FDA in a NIMS compatible format.
DSIMS⢠(Drug Safety Information Management Suite) Overview
The first in our three part webinar series on âDSIMS as a Service solution offering,â will provide an overview of the capabilities of DSIMS to meet regulatory reviewer needs for analysis, visualization and reporting on submitted studies. We will also provide hosting, qualification and validation details about the DSIMS service.
Data Standardization Tools, Tips and Tricks for FDAâs e-Data / CDISCÂŽ SEND Submission
For more information, please contact: get_started@pointcross.com
Uncovering Data Challenges as You Prepare for Submitting CDISCÂŽ SEND / e-Data to the FDA
For more information, please contact: get_started@pointcross.com
Achieving Compliance with the FDAâs e-Data / CDISCÂŽ SEND Submission Initiative
For more information, please contact: get_started@pointcross.com
Preparing for Nonclinical eData Regulatory Submissions to the US FDA-âSENDâ and Beyond
Presenters: Shree Nath, PhD, Vice President, PointCross Life Sciences Timothy J. Kropp, PhD, Team Leader, Tools Technology and Innovation Team, US Food and Drug Administration The recording of this webinar is no longer available from the American College of Toxicology but the presentation slides are available for viewing.
What does SEND Readiness mean for your company? – Webinar
Watch the replay of this webinar held on June 27 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 become conversant with new ways of representing their data....
Hosted Webinar: DSEC Panel Discussion: Search, Analytics and SEND: Guarding Your Drug Safety Blind Spots
Sponsored by PointCross Life Sciences The FDA has announced its intent to mandate nonclinical data submissions in standardized formats like SEND. Consequently, Agency reviewers expect to be spending more time on data analysis and detection of potential safety signals across studies. To guard against blind spots in your drug development lifecycle, wouldnât you want 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.
PointCross Life Sciences Drug Safety Information Management Suite
PointCross Life Sciences' DSIMS is a suite of software applications, repositories, tools, viewers, customizable workflows and stage-gated processes, and enabling technologies for accessing and managing nonclinical study data for researchers, toxicologists, reviewers, and regulatory reporting staff. DSIMS has a hub-and-spoke architecture for safety data. The hub is the NSDR repository, which has, at its...
PointCross Life Sciences ToxVision++
PointCross Life Scienecs ToxVision++ is a viewer that extends the reach and power of the original ToxVision viewer to provide new ways to visualize, compare, and evaluate nonclinical study data in a single, standards-based environment. In a single tool, ToxVIsion++ reseolves how GLP data is received, stored, displayed, charted, extracted, reported, and how basic...
PointCross Life Sciences ToxVision
ToxVision is the first viewer designed to automate the visualizing and normalizing of study data; ensuring the safety of drugs submitted for regulatory approval. Developed by PointCross Life Sciences, in collaboration with the FDA, Toxvision reads SEND data, making it easier for you to spot important signals and trends among a huge volume of...
Study Data Integration & Search (SDISâ˘) 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.
PointCross Life Sciences SDIS⢠Video
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.
Molecular Medicine Tri-Con
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
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.
PHUSE US CSS 2020 PP08 : Taking full advantage of the SEND data potential
Jointly published by Roche and PointCross Lifesciences
Visualization of âReal Timeâ Data from Ongoing Non-Clinical Studies in Support of Study Monitoring and informed Decision Making
PointCross will be holding a joint presentation with Roche | 9thâ13th November
PhUSE EU Connect: Amsterdam
November 10 -13 A live demo of our offerings or learning more about the release of our eDataValidator.
CDISC SEND Face to Face at FDA
April 1 - 5, 2019
PhUSE CSS Computational Science Symposium
March 4 â 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...
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 (Â 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,...
Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog
Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog (Â FDA Announcement;Â FDA Data Standards Catalog) Our Software solution (Xbiom) and services are set up to accommodate DART IG 1.1, and we have been generating SEND datasets for DART studies including EFD, Fertility and Early Embryonic Development and Pre-Natal and Post Natal...
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:Â 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 FDAâs...
PointCross Life Sciences and Smithers Avanza forge strategic partnership for SEND solutions
For biopharma companies, this collaboration will streamline the flow of high quality CDISC SEND standardized data for regulatory submissions required by the FDA and to serve sponsor R&D needs Silver Spring, MD, November 9th, 2015 PointCross Life Sciences and Smithers Avanza announced today that they have entered into a partnership to provide SEND solutions to their Toxicology Services clients....
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 EXICAREâs Location in Tokyo Japan and PointCross Life Sciencesâs Location in Foster City, CA, August 24th, 2015 â PointCross Life Sciences and...
PointCross announces SaaS offerings on the cloud to span the entire lifecycle of eData submissions to FDA
Nonclinical Study Data Specification(NSDS) for the definition of a study before it begins, and ToxVision-as-a-software-Service to review studies after they are completed using the same visualization and analysis tools as in FDAâs NIMS are now available as a software subscription. Silver Spring, MD, June 8, 2015 â Today PointCross announced two new SaaS offerings to complement its DSIMS-as-a-Service solution. These new...
NIMS Version 2.5 for SEND released to the FDA, Now Available for Industry
NIMS enables faster, deeper and more insightful regulatory review of nonclinical study data for safety signal detection and analysis Silver Spring, MD, March 12, 2015/ PRNewswire PointCross Life Sciences today announced that the FDA has accepted NIMS version 2.5 for operational use to review nonclinical CDISC SEND data that accompany NDA, BLA and IND drug applications....
PointCross announces SEND-ASSURE for Data Consistency in Submissions to the FDA
SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions Silver Spring, MD, March 9, 2015/ PRNewswire PointCross Life Sciences today announced the launch of its SEND-ASSURE audit solution to help pharmaceutical companies avoid the consequences of submitting standardized nonclinical data that is inconsistent with their study reports. CDISC SEND standardized data is required...
FDA awards IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats
FDA awards $20M IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats FOSTER CITY, Calif., Sept. 26, 2013 /PRNewswire PointCross Life Sciences, Inc. announced that it has been awarded an IDIQ contract with a cap of $20 Million by the U.S. Food and Drug Administration...
PointCross Life Sciences Opens New Office in Silver Spring, MD for Data Standardization of Nonclinical Studies
PointCross Life Sciences Opens New Office in Silver Spring, Maryland for Data Standardization of Nonclinical Studies FOSTER CITY, CA, July 9, 2013 PRNewswire Extending its recently announced Data Standardization Service, PointCross Life Sciences announced that it has opened a new center in Silver Spring, MD, USA where studies submitted by sponsors to the FDA in PDF...
PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions
PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions FOSTER CITY, CA, June 6, 2013 PRNewswire PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDAâs NIMS...
PointCross Life Sciences named to Gartnerâs 2013 Cool Vendor List for Life Sciences
PointCross Life Sciences Named to Gartnerâs 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 âCool Vendors in Life Sciences, 2013â š by Gartner, Inc. PointCross Life Sciences is a leading provider of solutions designed to unleash the...
PointCross Life Sciences’ SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDAâs Upcoming e-Data Submission Mandate
Press Releases PointCross Life Sciencesâ SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDAâs Upcoming e-Data Submission Mandate FOSTER CITY, CA, March 11, 2013 PRNewswire As a result of PDUFA V, the FDA will soon require Biopharma companies to submit their nonclinical study data in standardized electronic formats such as CDISC SEND, the Standard for...
PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management Suite
PointCross Life Sciences Announces DSIMSâ˘: Drug Safety Information Management Suite FOSTER CITY, CA, March 12, 2012 PRNewswire The FDA has announced its intention to require Pharma companies to include nonclinical study data in standardized electronic formats as part of regulatory IND, NDA and BLA submissions. This directive is intended to help FDA reviewers better predict safety...
PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services
Press Releases PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services FOSTER CITY, Calif., Oct. 3, 2011 PRNewswire PointCross Life Sciences, Inc. has announced that it has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the U.S. Food and Drug Administration to provide an integrated off-the-shelf software environment comprising of...