eShowcase: Data JumpStart
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.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
