news roundup

Alzheimer's Study Adopts BYOD Model

Datacubed Health's app, platform and web-based portal will be used by scientists at the Dominantly Inherited Alzheimer Network (DIAN) at the Washington University School of Medicine in Saint Louis.

Phlexglobal Addresses New TMF Guidance from EMA

Phlexglobal announced an important industry advisory around the new European Medicines Agency guidance on Trial Master Files that took effect on June 6.

Unified Clinical Operations Survey Results Released

According to the Veeva 2019 Unified Clinical Operations Survey, there is an industrywide drive to streamline trial processes and systems for better study visibility and collaboration. Research from the survey finds that 100% of respondents surveyed report the need to improve information exchange among study partners.

Roche, IDDI Publish Data Around DFS in Breast Cancer

Commissioned by Roche Germany, IDDI has found data that suggests that it is appropriate to use disease-free survival as a surrogate for overall survival in trials in HER-2-positive breast cancer.

Articles

2018 FDA Approvals Examined

Ken Getz examines the 2018 FDA approvals with insights, saying "What is most notable about 2018's approval volume is not only the scientific innovations that produced them, but also where they originated, how they were funded, and the operating models, services, and technology solutions that supported them throughout the R&D process."

Risk-Based Quality Management

To address the possibility of overlooked risk communication, a basic set of factors relevant to ensuring study quality should be identified for each study. Emphasis should be given to those factors that stand out as critical to study quality.

Ask the editor

Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com