CLINICAL RESEARCH STRATEGIES
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.
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
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.
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?
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.