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Alethea Wieland

Managing Expert, Advarra

Wieland is a managing expert for Advarra, bringing 30-plus years of expertise in analyzing the intersection of healthcare innovation and policy. As part of the Advarra Consulting team, Wieland provides invaluable insight into various biopharmaceutical companies, resulting in highly successful market launches. Additionally, Wieland is the President and COO of Clinical Research Strategies, which has consistently and successfully provided flexible clinical trial resourcing and developed sustainable corporate affairs programs and policies for life science companies. Wieland is especially passionate about helping sponsors and sites mitigate the risks of clinical trials and facilitates transparent, accountable sponsor-CRO partnerships. She is the recipient of the 2017 Governor Tom Wolf Recognition in PA Life Sciences, 2017 Women in Bio P.O.W.E.R. Award, and 2017 Pittsburgh City Council Recognition in Life Sciences. In April 2022, Wieland was named to the National Small Business Association (NSBA) Leadership Council and is a participant in the Small Business Technology Council (SBTC). 

Latest Posts by Alethea

 
Blog

Top 3 Reasons Why Your Medical Device Needs a Clinical Trial

Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.

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4 min. read
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Webinar

Is Your Site Ready for an FDA Inspection?

Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.

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Webinar

Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software

Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.

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Webinar

Inspection Readiness: Before. During. After

This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.

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Blog

Regulatory, Clinical, and Quality Considerations for Device Research

Medical device manufacturers are facing increasingly complex pathways to successfully bring their innovative ideas to the market.

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5 min. read
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Webinar

Tips for Accelerating Your Medical Device through the Product Lifecycle

Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.

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