Episode 34 – Real-World Data for Medical Devices with Alethea Wieland
With the new technologies as the Apple Watch, Fitbit or other application, we can now collect more data or more Real World Data.
This will be the topic of today´s podcast. Alethea Wieland from Clinical Research Strategies will help us understand the concept of Real World Data for Medical Devices.
- What can we do with this information?
- What are the parameters we should consider?
- Can we show them to Regulators to confirm our products are safe?
We will try to answer all those questions.
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.