News

BioCelerate Launches Two New Initiatives and Expands Membership

Jun 10, 2019

BioCelerate announced a collaboration with the Food and Drug Administration (FDA) to launch a joint working group which will explore methods to enable more effective analysis of nonclinical studies across the research community. Discussions are aimed at supporting more efficient and data-driven decision-making during early-stage research and development.

The collaboration between the BioCelerate and FDA stems from conversations around BioCelerate’s past work in data sharing and recently launched initiatives that focus on nonclinical study optimization:

  • The SEND Implementation for Cross-Study Analysis initiative is evaluating barriers and opportunities for using SEND data sets for cross study comparisons and analysis. Results of the evaluation may serve as future recommendations for CDISC, the standard setting organization governing the SEND data standard.
  • The Common Templates for Nonclinical Studies initiative has produced a draft protocol template for repeat-dose toxicology studies that is designed to help CROs and sponsors by reducing errors, improving operational efficiencies, and reducing costs during the interpretation and execution of studies. This team is currently evaluating public feedback on the draft and planning additional discussions with stakeholder groups later this year to further improve upon the template.

TransCelerate BioPharma Launches Three New Initiatives and Expands Membership

May 23, 2019

TransCelerate announced it has committed to an expansion of its clinical and drug safety portfolio, revealing three new initiatives: the Common Clinical Serious Adverse Events Fields Initiative, the Modernization of Data Analytics for Clinical Development Initiative and the Interpretation of Guidances and Regulations Initiative.

TransCelerate Identifies Pharmacovigilance as an Operational Challenge in Need of Transformation

Mar 30, 2017

TransCelerate has added Pharmacovigilance to its portfolio, establishing two new global initiatives: 1.) Interpretation of Pharmacovigilance Regulations and 2.) Value of Safety Information Data Sources. Both initiatives aim to create solutions that will reduce resource inefficiencies, enhance information exchange with global health authorities and improve patient safety to drive more value for patients.