Sage Submissions
has released Sage Templates, version 1.1.3. Sage Templates OneVoice feature enables documents to be created across the organization and by outside authors with a consistent look-and-feel. This enables the creation of consistent formatted submissions instead of several formats and document navigation structures.
Extensive customer input was gathered to enhance the design of Sage Templates and to extend the number of templates available to authors of submission documents with Version 1.1.3. Sage Templates are available as a complete set for all stages of submissions in North American and Europe and includes:
· US eCTD
· EU eCTD
· IND
· CTA-IMPD templates for Europe and
· CTA-A templates for Canada
Templates are also available as subsets to provide a low cost acquisition point for companies that prepare Drug Master Files, CROs that conduct nonclinical or clinical studies, or companies that submit only IND, CTA-IMPD or CTA-A submissions.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.