• 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.

  • What’s Really Behind The CRA Shortage In Clinical Trials? A Root Cause Analysis

    The #1 and #2 complaints I hear consistently from peers and partners in life sciences companies are the inability to hold third-party partners and CROs accountable for quality performance and to have a consistent experienced team over the life of their clinical trial. The two are inextricably linked.

  • RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward

    This is the second 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. In this part, we will explore the challenges and opportunities RWE presents for life sciences companies, review two recent examples, and discuss how this newer way of thinking will transform the way we design and conduct clinical research or evaluate value-based decisions for the better.

  • 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 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,