Life Sciences News

  The Analysis Data Model is one of the most crucial requirements for clinical trial submission (ADaM). The creation of analysis datasets and related metadata is described in   ADaM   standards. This ensures traceability and makes it easier for a statistical programmer to produce figures, listings, and tables. As a result, reviewers can evaluate and approve a submission more rapidly. SDTM and ADaM go hand in hand: The first thing to understand is how interconnected ADaM and SDTM are, despite the fact that they may serve distinct purposes. Let's first examine their differences before seeing how they interact. SDTM (Study Data Tabulation Model) The model (or framework) used to arrange data from clinical trials including both humans and animals is known as CDISC  SDTM . The purpose of SDTM is to clearly describe the structure, characteristics, and contents of each dataset as well as the variables you submitted as part of your clinical trial to regulatory reviewers, spec...

  PointCross Life Sciences launches an automatic SEND Quote Generation tool, intended to save industry time and effort in generating a highly competitive, indicative SEND generation or QC quote - including for those requiring a fast-track turnaround. PointCross SEND process ensures a 100% consistency and reconciliation against the GLP Study Report, and is accompanied by the nSDRG, Define, and validation files. SEND studies that PointCross processes or quality checks are also delivered on the Xbiom ™ visualization and analysis platform. Feel free to use the tool (link below) to generate a free, no-commitment indicative quote for your SEND needs, whether it is to generate the full SEND package or 100% QC an existing SEND dataset that you are preparing to submit. Link to SEND Quote Generation tool: https://pointcrosslifesciences.com/send-generation/

  The availability of the Nonclinical Digital Study Report (DSR) is an exciting development that has the promise of making SEND better, safer to use, and actually useful for analysis. DSR is available in machine-readable columnar tabulation, making it easy to use the same tools used to read CDISC ’s SEND. DSR retains the same data domains and terminology of observation and testnames as in the Study Report. DSR is a machine-readable companion to the published PDF Study Report. DSR includes all the required study metadata, trial design domains reflecting the protocol, and the summary tables in the study report. DSR also carries a digital extracts of the Study Director’s “Results and Conclusions” in machine-readable form. A complete DSR may also include the individual subject level findings. SEND is a CDISC standard for exchange of Nonclinical Study Data. In practice, SEND is almost always generated separate from the process that generates the Study Report, but using the same data c...

  PointCross Life Sciences   recently collaborated with   Sunil Gupta   at the   PHUSE   Winter Single Day Event in beautiful Cary, North Carolina. Refer to the paper below that introduces a way to automatically map EDC raw data and metadata to SDTMs and ADaMs through the Universal Data Model (UDM) on Xbiom. Quick brief:  The Universal Data Model (UDM) offers an attractive method to traditional SDTM programming and mapping. Non-programmers can access a simple, low-code interface for control and visualization of EDC raw data to SDTM mapping through a universal data model which standardizes all metadata (files, variables, data, etc.). Xbiom  from PointCross comes with built in SDTM conformance rules, and leverages EDC raw data and metadata attributes to strategically compare and map them to SDTM metadata and control terminology variables and derivations. Users then visually review and confirm Xbiom’s recommendations of each SDTM variable mapping and...