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.

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LIVE EVENT: Wednesday, November 3, 2021, 12:00 pm – 1:00 pm EDT

The Future of DCTs: Are You Prepared?

with Alethea Wieland, Founder and President of Clinical Research Strategies in conjunction with ACRP

This webinar is tailored for professionals in the research field who wonder how to embrace the changes in DCT research. Discussion includes a practical guide for what DCT really means, how there is no going back, and more importantly, how it is up to the research professional to adapt to change. We will cover discussion for Sponsor management identifying new training modules for staff; career CRAs who face new challenges to the monitoring ups and downs; site research personnel struggling to cope with the new rules and higher responsibilities to provide for remote monitoring; and, others who may have been affected by job loss during the global pandemic. Further, we will discuss the technology changes that we should expect to see in the next decade.

Upon completion of this Webinar, attendees should be able to understand and identify:

  • Provide background to make sense of DCTs relative to your career path
  • Furnish a tool kit to participate in the transformation for professional growth
  • Acknowledge the uncertainty of change but to be in a position for personal success

ACRP supports clinical research professionals through membership, training and development, and certification. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. LEARN MORE


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.


An End-to-End Approach to Compliance in Life Sciences

Life Sciences Review, March 2021

“In the EU, while regulations are meant for ensuring patients’ safety by adding more conformance requirements, they have severely compromised the Life Sciences industry’s quest to push the boundaries of innovation,” says Alethea Wieland, the President and Founder of Clinical Research Strategies.

According to a study published by Deloitte, “Globalization, alliances and partnerships, heightened transparency expectations, increased emphasis on innovative technologies, and ever-evolving needs for existing and emerging customers are driving them to re-examine their approach to compliance.”

As such, identifying, analyzing, and mitigating compliance risks have evolved into a fundamental prerequisite for Life Sciences companies in developing an effective strategy to help future-proof their business. However, keeping up the innovation pace with this regulatory landscape will no longer be an easy task, especially for startups and mid-sized organizations.

Life Sciences Review Article

Read the full article online at Life Sciences Review.


Conducting Clinical Trials and Human Factor Studies During COVID-19 Pandemic for Novel, Non-Contact Mobile-Digital App, InteloMed TeleHealth Technology (ITT!), that Detects Respiratory and Pulse Rates through Android or iPhone Camera

Alyssa Harris, MS, Clinical And Regulatory Affairs Project Lead
Clinical Research Strategies

Doctor Holding SmartPhone



Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?

By Alethea Wieland — Clinical Leader, July 14, 2020

We have all these new nifty ways to conduct research, and the regulators are initiating new conversations about how we need to conduct research, but the guidelines and regulations we follow lag behind the digital transformation. This article shares some thoughts on the current state of regulatory science, by reflecting back on two prominent meetings. READ MORE

What’s Really Behind the CRA Shortage in Clinical Trials?
A Root Cause Analysis

By Alethea Wieland — Clinical Leader, March 8, 2020

The #1 and #2 complaints I hear consistently from peers and partners in life sciences companies are the inability to hold third-party partners and CROs accountable for quality performance and to have a consistent experienced team over the life of their clinical trial. The two are inextricably linked. READ MORE

RWE in Clinical Research:
Challenges, Opportunities, and 2 Case Studies to Move Us Forward (Part 2)

By Alethea Wieland — Clinical Leader, September 26, 2019

This is the second article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. READ MORE

Real-World Evidence in Clinical Research:
We’re Not in Kansas Anymore (Part 1)

By Alethea Wieland — Clinical Leader, September 19, 2019

This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. READ MORE

What is Taking So Long for Meaningful Interoperability in Clinical Research?

By Alethea Wieland — Clinical Leader, June 6, 2019

Countless digital technological advances, data warehouses, and hardware and software programs have made our jobs more repeatable, less erroneous, and faster. Yet, we still have not made significant progress on interoperability between disparate electronic systems. READ MORE


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


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.

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.

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.


Every Sponsor’s Top 10 Checklist for Selecting a CRO

This Top 10 Checklist is a helpful starting point that can be further expanded as necessary to help Sponsors de-risk the objectives of conducting a successful clinical trial.

Selecting a CRO Doc

Lessons Learned from a Rescue Trial

A clinical trial rescue is perhaps one of the worst realities that prior decisions during the due diligence, proposal review, bid defense, and ultimate award to a CRO partner failed. What ultimately goes wrong?

CRS Lessons Learned Rescue Trial Doc


What Most Medical Device Companies Face and How to Succeed

A first-hand view of challenges, best practices, and winning factors garnered through extensive work with early stage medical device companies.

The “Essential Guide: What Most Medical Device Companies Face and How to Succeed” has been authored by expert Alethea Wieland, Founder and President of Clinical Research Strategies.

CRS Essential Guide Cover
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