Cloud-based solution allows investigators to simplify the development of clinical research protocols.
Protocol Builder, a cloud-based solution for investigator-initiated clinical trials, is now available to individual researchers, including medical residents and fellows, according to the Biomedical Research Alliance of New York (BRANY), the developer of the system. The tool, originally developed as an enterprise solution, provides instructions and relevant tips developed by experts. A built-in Resource Center allows investigators to access protocol samples as well as links to important educational and regulatory information. Users can also download commonly used forms.
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.