Newsletter | March 17, 2023

03.17.23 -- Are Baseline Measurements Reliable? How RWD Can Help

 
     
 
     
 
  Sponsor  
 
 
 
Webinar: Unlock The Power Of Data Review And Collaboration — Maximizing Trial Success
 

Join us to discover how leveraging dynamic workflows to review, query, track, and collaborate cross-functionally in a clinical trial can result in better trial conduct, potential study amendments, and evolving clinical strategies. Click here to learn more.

 
 
 
     
 
Trial Monitoring
     
Takeda Takes A Strategic Approach To TMF
 
 

Over the past five years, Takeda has been perfecting its all-in model for TMF, where both Takeda and its CRO partners collaborate in Takeda's eTMF. This enables transparency into TMF health across the partnership and drives more effective, proactive collaboration.

 
 
 
 
     
Using Risk-Based Monitoring To Focus On Timelines, Quality, And Budget
 
 

Tanya du Plessis, VP of data solutions and strategies at Bioforum, and Rich Davies, VP of solutions expert at CluePoints, explain the principle applications of RBQM to data management.

 
     
Satisfying Critical Requirements With Risk-Based Quality Management
 
 

Learn how ThoughtSphere’s comprehensive RBQM facilitates the complete risk lifecycle from risk identification through issue resolution with automated triggers and configurable user workflows.

 
     
     
 
Clinical Data Management & Analysis
     
Are Baseline Measurements Reliable? How RWD Can Help
 
 

Baseline measurements presume to establish physiological and/or metabolic status before introduction of test drug(s). But what if they aren't truly reflective for a particular patient? Introducing real-world data (RWD) might be the answer for improved accuracy.

 
 
 
 
     
How Does Engineering Make Clinical Research More Accessible? Part 2: Milestones On The Path To Innovation
 
 

How can engineering make the world a healthier place? Join the discussion and explore the path to innovation, including data tracking strategies and steps to securing project funding.

 
     
3 Things To Know When Using Wearables In Your Study
 
 

As wearables unleash new possibilities, the industry will need an effective strategy to utilize these useful tools. Consider these tips when incorporating wearables in a clinical study.

 
     
Time-To-Event Analysis In Oncology Through The Prism Of Estimands
 
 

Considering an ICH E9R(1) Addendum on Estimands and Sensitivity Analysis, several sensitivity analyses are now regarded as supplementary analyses. Learn about these changes and their effects on oncology trials.

 
     
How To Double High-Performing Site Count In A Priority Indication
 
 

A Top 10 biopharmaceutical company wanted to expand its site list in a priority indication and better understand how existing sites in their database performed. Find out what happened next.

 
     
Zelta: The Clinical Data Management And Acquisition Of Choice
 
 

Discover how to accelerate clinical trials with unmatched control and confidence.

 
     
     
 
Choose Your Own Adventure
 
 

You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

Learn more about our personalized newsletters here.