MEDIA & EVENTS

Regulatory Pathways to Clearance: Transitioning University Discoveries

School of Health and Rehabilitation Sciences Innovation Seminar Series at the University of Pittsburgh

Dr. Julie Cramer, Associate Director of Clinical and Regulatory Affairs of CRS

During this talk, Dr. Cramer provides a regulatory perspective on how to transition your device-based discoveries out of the University. She discusses topics such as how to define your medical device, differences between your device’s intended use and indication, types of device market approval applications/pathways, and Regulatory Pathway Assessments.

1. Defining your medical device
2. Intended use vs Indication
3. Types of device market approval applications/pathways
4. De-risking the process
6. Meeting with the regulators
7. Clinical evidence generation

Watch the Video Presentation

FREE ON-DEMAND WEBINAR!

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

with Alethea Wieland, Founder and President of Clinical Research Strategies, and presented by Greenlight Guru

Join clinical trial expert Alethea Wieland as she presents her most valuable tips and tricks to help clinical, regulatory, quality, and marketing teams develop a clinical trial program that fulfills global compliance requirements, meets the needs of patients in various regions around the world, and serves as an ongoing compendium of evidence generation.

Webinar Title Screen

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AACC Pittsburgh Event Banner

Bridging the Gender Race Divide / Asian American Chamber of Commerce

Clinical Research Strategies’ very own Parul Nisha, PhD, spearheaded Pittsburgh’s Asian American Chamber of Commerce entrepreneurship event at Carnegie Mellon University on May 7, 2022.

May is Asian American Pacific Islander Heritage month. This event celebrated their heritage with a day-long program featuring an Entrepreneurship Keynote and Leadership Round Table with eminent local thought leaders, along with a panel discussion on diverse topics – Biotech, AI/Robotics, Cybersecurity, Finance, Music, Art and Media. The Biotech entrepreneurship panel featured Susan Catalano, PhD, Kanak Iyer, PhD, Hyagriv Simhan MD, MS, and CRS founder, Alethea Wieland.

CMU Panel Discussion

The Biotech entrepreneurship panel featured Susan Catalano, PhD, Kanak Iyer, PhD, Hyagriv Simhan MD, MS, and CRS founder, Alethea Wieland.

Praul Nisha, PhD and Kanak Iyer, PhD organizers of the Pittsburgh inaugural event by the Asian American Chamber of Commerce, held at the Swartz Center for Entrepreneurship at Carnegie Mellon University are featured on KDKA news, May 7, 2022.

THE HUXLEY MORTON PODCAST

Series 3 Episode 5 – August 4, 2021
Addressing the unmet needs of the life sciences sector!

James Fowl interviews Alethea Wieland, Founder and President of Clinical Research Strategies

This podcast helps Pharma & Biotech industry professionals to learn from others sharing their insights from all over the world. It’s perfect for both aspiring leaders and experienced individuals looking to help make a positive impact in the world of Clinical Trials.

WEBINARS

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

Greenlight Guru Webinar, October 7, 2021

With Alethea Wieland, Founder and President of Clinical Research Strategies, and presented by Greenlight Guru. VIEW ON-DEMAND

Medical Device Clinical Trials: Strategies to Optimize & Accelerate Market Approval and Mitigate COVID-19 Impact

RGP Healthcare Webinar, September 16, 2020

RGP Healthcare invites you to an informative webinar with three leading medical device industry experts to explore what innovative solutions are being used not only to master the “new normal,” but to also emerge more competitive and efficient in the coming post-pandemic world. Join Alethea Wieland, Marcia Brown-Rayford and Karim Mohammed for this free webinar as they share cutting-edge strategies and insights on accelerating medical device clinical trials in today’s challenging healthcare environment. USE PASSCODE (Case-sensitive) k#s&s0M5 to VIEW ON-DEMAND

Maximizing the Benefits of a Unified Clinical Data Capture and Management Platform

Medidata Webinar, June 3, 2020

In today’s evolving ecosystem of clinical and medical device trials, Sponsors, Biotech companies, and CROs alike are faced with common challenges like managing multiple data sources, integrating data from disparate data systems, performing frequent reconciliation, and managing complex and comprehensive reporting requirements. This webinar discusses how leveraging multiple solutions on a unified platform streamlines processes, drives operational efficiency, eliminates reconciliation, and provides faster data insights. VIEW ON-DEMAND

The 5 Top Pitfalls for Early Stage Medical Device Companies and How to Avoid Them

Medidata EBP Master Class Webinar Series, December 4, 2019

Understand the costs and best locations to bring your product to market. In today’s era of vast regulatory reform, there are a number of advantages to looking at the US first. VIEW ON-DEMAND

Engaging with Regulators, What You Need to Know and Share and When

Medidata EBP Master Class Webinar Series, January 22, 2020

The FDA and other competent authorities are our collaborators. In this webinar we will go over the various types of meetings and how they can help you. VIEW ON-DEMAND

In-house or Outsource, Consultant or CRO? How to get the best bang for your limited bucks

Medidata EBP Master Class Webinar Series, February 26, 2020

The strength of the evaluation process of your CRO, vendors, and various partners can make or break a small life science business. VIEW ON-DEMAND

VIDEOS

GCP Mindset: Decentralized Trials with Alethea Wieland

December, 2021

GCP-Service’s GCP Mindset channel informs viewers about the latest trends and topics in clinical research. Here, they take a closer look on Decentralized Trials with expert Alethea Wieland from Clinical Research Strategies.

Pittsburgh Science Spotlight – Alethea Wieland Interview

October, 2021

In this third installment of Colliers Pittsburgh Science Spotlight, Colliers had the opportunity to speak with Alethea Wieland, President, Chief Operating Officer & Founder of Clinical Research Strategies.

Our Region's Business Interview

Our Region’s Business – Helping Life Science Breakthroughs to Market

July 2, 2021

Our Region’s Business has been jointly produced by the Allegheny Conference and WPXI-TV since May 2004. The show is hosted by Bill Flanagan, Chief Corporate Relations Officer at the Allegheny Conference on Community Development.

Live Virtual Roundtable: Maximizing the Benefits of a Unified Clinical Data Capture and Management Platform

Medidata Solutions – June 3, 2020

TOP 10 criteria to select a CRO for a Clinical Trial

Easy Medical Device, May 13, 2019

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your medical device clinical trial project.

Real-World Data for Medical Devices with Alethea Wieland

Easy Medical Device, July 29, 2019

Alethea Wieland from Clinical Research Strategies will help us understand the concept of real-world data for medical devices.

Medical Device Clinical Trials Practices with Alethea Wieland

Easy Medical Device, May 6, 2019

Alethea Wieland of Clinical Research Strategies helps 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.

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