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Medical Device Clinical Trials Practices with Alethea Wieland (Part 1 of 2)

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What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start one?

I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding of Medical Device clinical Trials. She will help beginners in this area to learn about the fundamentals of clinical trials.

This is the first part of 2 episodes. The second episode will be about “How to select a CRO?” So don’t miss it.

Alethea Wieland is Founder and President of Clinical Research Strategies, LLC, an executive-level management consulting firm and contract research organization for the life science industry established in 2011. Her focus is on offering agile, flexible staffing models for clinical trial resourcing; training and managing resilient, high-performing clinical operations teams using human-centered design techniques; and, mitigating risks of clinical trials by facilitating the best Sponsor-CRO partnerships who practice accountability, compliance, and transparency. She is an advocate of strong contractual arrangements, and frequently meeting with regulators and numerous stakeholders which results in a win-win mindset. Learn more by connecting with her on LinkedIn, and by visiting her website at

■ Links from the Video

► Clinical Research Strategies:
► Alethea Wieland Linkedin:
► Alethea Wieland Twitter:
► ISO 14155:
► Meddev 2.7/4:
► ICH Good Clinical Practice:
► Book: Rigor Mortis – Richard Harris:

■ Social Media to follow

► Linkedin:
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#Clinicaltrials #medicaldevice #compliance