ARTICLES BY ALETHEA WIELAND
Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?
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
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?
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.