Newsletter | January 17, 2023

01.18.23 -- Digital Vs. Decentralized Trials: Meeting The Implementation Challenges

 
     
 
     
 
 
 

Welcome to the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial ManagementUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
 
 
     
 
Decentralized Trials
     
Digital vs. Decentralized Trials: What’s The Difference And How Do I Meet Implementation Challenges?
 
 

Digital clinical trials, which have gained momentum since the onset of the pandemic, have the potential to address many of the inefficiencies of traditional trials. This article defines digital clinical trials and how they differ from decentralized clinical trials, as well as how to meet implementation challenges.

 
 
 
 
     
Should You Incorporate Home Nurses Into Your Next Clinical Trial?
 
 

Explore why the clinical trials industry is shifting even further toward the routine incorporation of home visits into their studies.

 
     
How Level Of Touch Guides Decentralized Clinical Trial Tools And Methods
 
 

To run clinical trials quickly, safely, and with high data integrity, learn why it is effective to assess trials by degree of touch.

 
     
     
 
Trial Management
     
The Long-Term Impact Of COVID-19 On Clinical Trials: Part 2
 
 

The COVID-19 pandemic is helping create a “new normal” for the life sciences industry regarding the policies, procedures, and processes of clinical trials. In Part 1, we discussed five factors that more directly impact the clinical trial process and patients. In Part 2, we will discuss six factors that focus on organizational structure and the broader industry. 

 
 
 
 
     
Why You Need A Remote-First CRO Powered By Purpose-Built Software
 
 

Discover why having the right CRO for a digital therapeutics study can have a serious impact on the trial efficiency and regulatory success of the study. 

 
     
Driving The Future Of Medicine Through Clinical Trials
 
 

Personalized medicine represents unprecedented potential benefits for patients, yet it also brings new challenges for those conducting the clinical trials. Explore these challenges in the available case study.

 
     
The Japanese Market Presents Opportunities For Drug Development
 
 

Gain insight into how small and midsize pharma sponsors can successfully navigate the challenges of Japan's clinical, regulatory, and cultural environment, especially since in recent years the country has worked to ease market barriers and streamline approval processes.

 
     
How To Optimize The Contracting And Budgeting Process
 
 

The period from pre-site visit to contract and budget execution typically takes many months and represents the majority of study start-up cycle time. Read about an effective strategy to shorten long contract cycle times.

 
     
Intelligent IRT Design Process Accelerates Digital Enablement At Sites
 
 

Cenduit IRT study design teams took on the challenges pressing biopharmaceutical industry sponsors as they worked to digitally enable sites and speed up time to first-patient-in for COVID-19 therapeutic and vaccine trials.

 
     
Distributing Clinical Supply In The EU For Compassionate Use Programs
 
 

Explore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.

 
     
Optimizing Clinical Supply Chain Management In Clinical Trials
 
 

In this webinar, clinical operations teams, project managers, and clinical research coordinators will learn best practices to optimize clinical supply chain management.

 
     
Phlexglobal Experts Fill The Gaps In eTMF Management
 
 

Phlexglobal’s unmatched expertise working in any eTMF system is enabling busy study teams to assess, prevent, and manage risk across the entire TMF spectrum – improving inspection-readiness with less effort.

 
     
Real Solutions To Challenges In Clinical Trials For Cell And Gene Therapy
 
 

Cmed is highly experienced in the management of cell and gene therapy clinical trials, whether in oncology, rare diseases, or other therapeutic areas.

 
     
Endocrine And Metabolic Expertise To Enable Your Success
 
 

Veristat has built a team of scientific-minded experts who have supported more than 300 projects for endocrine/metabolic disorder treatments and prepared over 30 marketing applications, 60% of which have been approved or authorized to date.