RESOURCES

VIRTUAL CLINBIZ SUMMIT 2020

September 15-17, 2020 Fully Virtual Summit! Fully Online!

Please join Clinical Research Strategies at the Virtual ClinBiz Summit 2020 taking place this September 15-17 fully online! It will be a virtual conference to remember with timely and relevant presentations, panel discussions and online workshops to keep you updated on the latest topics, trends and technologies surrounding the business operations aspects of your clinical trials. Have your teams attending remotely by registering today at www.clinbizsummit.com. See you there!

Use this promotional code at registration for a 15% discount: speakerguest

PUBLISHED ARTICLES

 

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

WEBINARS

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

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.

DOWNLOADS

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

ESSENTIAL GUIDE

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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