Episode 22 – Clinical Trial with Alethea Wieland
What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation?
I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials.
This episode is really a masterclass for people that are not clear about Medical Device requirements for Clinical Trials or Investigation. We will talk about Europe but also the USA, and some other countries in the World. On the show notes, I also included some of the references that Alethea is mentioning as Standards, regulations or books to read.
This is the first part of 2 episodes. The second episode will be about “How to select a CRO?” So don’t miss it.
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Who is Alethea Wieland
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 www.clinicalresearchstrategies.com.
► Clinical Research Strategies: https://www.clinicalresearchstrategies.com
► Alethea Wieland Linkedin: https://www.linkedin.com/in/alethea
► Alethea Wieland Twitter: https://twitter.com/alethea_wieland
► ISO 14155: http://tidd.ly/35fb9ead
► Meddev 2.7/4: https://ec.europa.eu/docsroom/documents/10336/attachments/1/translations/en/renditions/native
► ICH Good Clinical Practice: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
► Book: Rigor Mortis – Richard Harris: https://amzn.to/2ZXlphG
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