PointCross Blog

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...

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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...

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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...

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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...

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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...

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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...

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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...

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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,...

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SEND DART is now supported by PointCross Life Sciences

Support for SEND DART IG 1.1 as 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...

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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,...

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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.

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