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.

Alethea-Wieland

Alethea Wieland

Alethea Wieland is founder and president of Clinical Research Strategies, LLC, an executive-level management consulting firm and boutique, functional service provider for the life sciences industry. Her firm’s solutions include analyzing the intersection of healthcare innovation and policy; providing flexible clinical trial resourcing; developing sustainable corporate affairs programs and policies; training and managing resilient, high-performing clinical operations teams; mitigating risks of clinical trials; and facilitating transparent, accountable sponsor-CRO partnerships. Learn more by connecting with her on LinkedIn, and by visiting her website, www.clinicalresearchstrategies.com.