► Webpage: https://podcast.easymedicaldevice.com
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 www.clinicalresearchstrategies.com.
■ Links from the Video
► Clinical Research Strategies: https://www.clinicalresearchstrategies.com
► Alethea Wieland Linkedin:
► Alethea Wieland Twitter:
► 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
■ Social Media to follow
► Linkedin: https://linkedin.com/in/melazzouzi
► Twitter: https://twitter.com/elazzouzim
► Pinterest: https://www.pinterest.com/easymedicaldevice
► Instagram: https://www.instagram.com/easymedicaldevice
#Clinicaltrials #medicaldevice #compliance