Clinical Trials: Understanding the Basics, Types, and FAQs
Clinical trials are an essential part of the drug development process, allowing researchers to evaluate the safety and effectiveness of new treatments. These trials involve testing a new medication or therapy on humans, usually in several phases, to determine its efficacy, safety, and potential side effects. In this blog post, we'll explore the basics...
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...
PointCross Incorporates PMDA Validation Rules V4
On February 28th, 2023, PMDA released a new validation rule version 4.0 for SDTM (Study Data Tabulation Model) and Define.XML. A major change in PMDA Validator Rules v4.0 is the support of SDTM IG v3.3, as well as the removal of support of Define.xml 1.0 PointCross Life Sciences has incorporated the updated rulesets on April 28th, 2023....
SDTM Automation: Streamlining Clinical Trial Data
Clinical trial data management is a complex process that requires the collection and analysis of vast amounts of data. To ensure data consistency, accuracy, and integrity, the pharmaceutical industry has developed the Standard Data Tabulation Model (SDTM). In this article, we will explore the significance of automation in clinical trials, particularly automated data mapping,...
EDC Raw Data to SDTM Curation, Mapping and Automation with the Xbiom Tool
At PHUSE US Connect 2023, PointCross Life Sciences presented a new way to automate the mapping of raw clinical EDC and non-EDC (biomarker) data to SDTM mapping through a Universal Data Model (UDM). Reducing the time to SDTM from weeks to days with built-in traceability, we discussed how SDTM programming and mapping for statistical analysis...
Webinar on Harmonizing Raw Data with CDISC Standards to Streamline SDTMs
Date: Thursday, January 19, 2023 Time: 09:00am PT / 12:00pm ET
Clinical and Nonclinical validation Tools
When it comes to clinical and nonclinical study submission datasets to the FDA or PMDA, there are multiple validation tools available. This article will talk about eDataValidator (eDV) from PointCross Life Sciences, which offers a strong and complete validation tools for both clinical and nonclinical studies. The eDataValidator is a single solution for IND, NDA, and BLA...
FDA SEND Dataset Services
Ensuring FDA Compliance with SEND Dataset Requirements: PointCross's Comprehensive Solutions The U.S. Food and Drug Administration (FDA) requires SEND (Standard for Exchange of Nonclinical Data) as a standard for nonclinical study data submission to the Center for Drug Evaluation and Research (CDER). SEND is a data standard mandate of CDISC SDTM standard for nonclinical studies...
SDTM – Everything that you need to know
What is SDTM? SDTM (Study Data Tabulation Model) is one of the requirements for data submission to the FDA (U.S) and PMDA (Japan). To facilitate data collection, management, analysis, and reporting procedures, SDTM offers a standard for organizing and presenting data. Implementing SDTM helps with data warehousing and aggregation, encourages mining and reuse, makes sharing...
Universal Data Model – PhUSE Americas Winter SDE
We presented a paper at the PHUSE 2022 Americas Winter Single Day Event on the topic of Universal Data Model (UDM) being leveraged to streamline pathways to SDTM and ADaM Standards. This paper introduces Xbiom to automatically map raw data to SDTMs. SDTM Automation By Reusability and Repeatability Leverage a Universal Data Model (UDM) to Streamline...
PointCross announces full complement release of eDataValidator
July 20 2022 – 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...
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...
Incorporating Histopathology data of organs and tissues for terminal subjects from a draft PDF report
Challenge: Necropsy data and histopathology results were available only as a PDF report after the study’s conclusion. The CRO-provided LIMS data for pathology was not available until a conversion to SEND had been done, well after the final PDF Study Report was generated. This prevented pathology findings and incidence counts from being cross-assessed against...
Sponsor conducting Xenograft studies on a tumor growth
Challenge: The study design is an involved lattice with multiple trial arms and with multiple CROs involved. Standard trial designs such as those in SEND are not sufficient. Tumor growth values are provided very frequently by multiple CROs. Sponsor-provided plasma concentration values are provided in Excel sheets. A method for estimating the inhibitory concentration...
Delayed PK data hampers clinical assessment
Delay in availability of Pharmacokinetic (PK) data from Bio-Analytics labs inhibits assessment of clinical pathology findings. Challenge: Pharmacokinetic Concentration (PC) calculations of the treatment and metabolites are generated from biosamples sent to bio-analytics labs. The PK modeling and generation of PK parameters such as Cmax and Tmax, AUC (for various timepoints), and Cav, reported in...
Case Study: Business Benefits from Monitoring of Ongoing Studies
Sponsor looks to use on-going studies to make tactical and strategic decisions on planned and future studies and their design sooner, rather than wait until the final study reports are published. Challenge: Completed studies were previously not readily available to the Sponsor in a machine-readable digital form, and only PDF study reports were available in...
Interim Study Monitoring Webinar
October 19th 2021
Orchestra™
Orchestra™ a web solution for all content managed within their contexts SOLO™ companion desktop software that synchronizes with Orchestra for offline Orchestra™ is an enterprise platform to: Unify management of all structured and unstructured content or data Self organize content into their business contexts within their ontologies Organize and serve an unlimited number of ontologies from any industry Index and...
SRR Files & Template
SRR (Study Report Reference) files are machine readable columnar formatted files generated using Study Report. SRR files is a valuable resource for software companies to compare and reconcile the summary tables data in the Study Report with the same summaries re-generated from the SEND datasets, which helps the data consistency check of SEND files. Please...
Case Study: Integrated Repository of Nonclinical Studies
Integrated Repository of Nonclinical Studies: A Case Study for a Centralized, Searchable Registry of all Nonclinical Studies for Drug Safety and Toxicology Research In this case study we describe how a major Biopharma ranked in the top three, uses Xbiom Nonclinical as a centralized, shared searchable repository of all ongoing, current and legacy studies across...