ARTICLES BY ALETHEA WIELAND

• Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?

  7/14/2020

  This article will share some thoughts on the current state of regulatory science, by reflecting back on two prominent meetings — the inaugural UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Summit and the Clinical Trials Transformation Initiative (CTTI) Virtual Meetings for Stakeholder Engagement on ICH E6.

• Real-World Evidence In Clinical Research: We're Not In Kansas Anymore

  9/19/2019

  This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules.

• What Is Taking So Long For Meaningful Interoperability In Clinical Research?

  6/6/2019

  Three decades ago when I entered the profession of clinical research, our workplace equipment extended to typewriters, white-out, mimeographs, hand-written documents, rubber erasers, pens, label makers, and fax and copy machines. Rows of massive, locked, fire-proof filing cabinets storing millions of papers for a nationally funded research program lined record rooms, hallways, and every spare corner of the offices. Most of us felt rewarded when we could use a typewriter with a correction key despite one’s typing skills being firmly judged by the illegible mistakes in the carbon copies.