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 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 BioPharma recently launched a clinical data sharing platform, DataCelerate. The platform incorporates preclinical toxicology data from the company’s subsidiary, BioCelerate, supporting toxicology data sharing amongst member companies.
DataCelerateTM Seamlessly Connects Clean, Converted Clinical & Preclinical Information within One Data Lake Solution.
TransCelerate announced the addition of several new initiatives to its expanded portfolio that leverage advancements in automation and analytics and focus on data quality, safety and integrity.
TransCelerate, with team members from Bristol-Myers Squibb Company, Janssen Pharmaceuticals, & GlaxoSmithKline, won first place in the Supply Chain Innovation Award competition at the Council of Supply Chain Management Professionals (CSCMP) EDGE Conference.
TransCelerate BioPharma Inc. announces Novartis joins as a Member Company, growing the consortium to 19 biopharmaceutical companies.
TransCelerate announced the availability of an enhanced technology enabled Common Protocol Template (CPT). This update to the CPT is in alignment with the common protocol template launched by the FDA and the NIH accessible here.
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.
Read this release about TransCelerate BioPharma Inc.’s measurable progress in its mission to help drive the efficient, effective and high-quality delivery of new medicines for patients through the sharing of data, and harmonizing on critical challenges in clinical trials.