Nonclinical Resources

Clinical All Resources

Webinars

SEND – A Year in Review

Title: SEND – 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...

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...

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 SaaS – For sponsors and CROs to collaboratively develop the Study Data Specification SWP SaaS – 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 SaaS –...

Lessons Learned from the 2015 PhUSE and SOT Conferences

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 and...

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 FDA’s Guidance that mandates future submissions in this format. Our experts will provide an overview of the standard, and the FDA’s 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...

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: 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 FDA’s Nonclinical Validator Specifications. The Nonclinical Validator Specifications reflect the FDA’s 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: 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 Agency’s 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 “Study View” is important for your FDA e-Data Submissions

To request a copy of the webinar presentation, please contact: get_started@pointcross.com Abstract We discussed how consolidating all the electronic data for a “Study” 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 can’t

To request a copy of the webinar presentation, please contact: 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 FDA’s Nonclinical Validator Specifications. Submitted studies considered pivotal are being standardized and loaded into NIMS for use by...

DSIMS™ (Drug Safety Information Management Suite) Overview

The first in our three part webinar series on “DSIMS as a Service solution offering,” 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.

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, wouldn’t you want to...

Demos

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 (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.

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.

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.

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,...

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 ( FDA Announcement; 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: 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 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 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 FDA’s NIMS are now available as a software subscription. Silver Spring, MD, June 8, 2015 – 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 FDA’s NIMS...

PointCross Life Sciences’ SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s Upcoming e-Data Submission Mandate

Press Releases PointCross Life Sciences’ SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s 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 DSIMS™: 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...