Case Studies

Case Studies

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 antagonist drug candidate needs to estimate the IC50 on a nonclinical study with multiple trial arms and treatment compounds.

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...

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 PDF format or Excel is not available in standard machine-readable format. The Sponsor was losing...

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 an unstructured repository in which findings were difficult to search and extract. Insights from findings must be published with substantiation and data along with the annotated insights, but searching across...