Data JumpStart helps companies deploy standardization and conversion solutions
Data JumpStart helps companies deploy standardization and conversion solutions
Octagon Research Solutions, Inc.'s (Wayne, PA) Data JumpStart assists companies in establishing data standards across their organization, as well as their outsourcing partners. Data JumpStart is an SDTM and CDISC compliant collection of documents, libraries, and templates.
It includes Case Report Form Library, a collection of 12 standard case report forms that leverage CDISC SDTM Nomenclature; Annotated Case Report Forms with SDTM variable names; Variable Names Library, which details variable names that can be used within each dataset categorized by dataset; CDISC SDTM compatible laboratory specifications for central lab vendors; Standard Query Library, which consists of approximately 50 standardized queries to provide consistent quality data; and Comprehensive Data Management Plan template, which includes 60 pages of expert guidance for the development of a data management plan.
Octagon Research Solutions, Inc., (610) 535-6500, www.octagonresearch.com
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.