Newsletter | April 12, 2023

04.12.23 -- Core Outcome Sets: What Are They & Why Are They Needed?

 
     
 
     
 
  Sponsor  
     
 
The Essential Checklist: Get Your eRegulatory and eSource Selection Right
 

Avoid complications and headaches when implementing an eRegulatory and eSource solution. Every platform is unique; however, there are essential assets you need to fully reap the benefits of a centralized, purpose-built solution. This checklist is designed to give you the tools you need to ask the right questions about potential eRegulatory solutions.

 
 
 
 
 
 
     
 
Decentralized Trials
     
Sites Look To Unravel The Tech Tangle Of DCTs
 
 

Decentralized clinical trials and all their elements are touted as flexible options for patients. But what about the sites carrying them out? Jimmy Bechtel of the Society for Clinical Research Sites (SCRS) says sites are looking for clarity and consistency when it comes to the tech being thrust upon them by sponsors and CROs.

 
 
 
 
     
Decentralized Trials Are Better Understood, But 5 Misconceptions Persist
 
 

Discover how one mobile research services and clinical trials provider addresses CRO and sponsor concerns associated with decentralized clinical trials.

 
     
Dispel Several Research Study Myths About DCTs
 
 

Unearth the truth and see how decentralized clinical trials are a fast-growing resource for sponsors to increase patient recruitment and retention.

 
     
Evolving Solutions To Optimize Clinical Trial Decentralization
 
 

The introduction of novel solutions to facilitate adherence can support decentralized trials and mitigate potential concerns surrounding reduced patient-physician touchpoints.

 
     
How Decentralized Clinical Trials Are Unlocking Research Potential
 
 

Explore the current DCT landscape and its evolution, as well as the key advantages of incorporating decentralized attributes and how barriers to their inclusion can be overcome.

 
     
Create Digital Biomarkers With Robust, Scalable Analytics
 
 

Clinical ink offers a best-in-class analytics platform to support the development and evaluation of digital biomarkers in clinical trials.

 
     
     
 
  Sponsor  
 
 
 
Webinar: Reducing The Impact Of Emerging Macroeconomic Pressures On Clinical Trial Supply
 

Join IRT industry veteran and drug supply expert Stefan Dürr as he discusses how to reduce the impact of both traditional and emerging macroeconomic pressures on clinical trial supply. Be sure to stay for the live Q&A, at which point you’ll have the opportunity to present Stefan with your biggest drug supply challenges. Click here to learn more.

 
 
 
     
 
Trial Management
     
What Core Outcome Sets Can Do — If We All Adopt Them
 
 

A single trial provides just a snapshot of evidence. Many trials provide a summative account of how effective an intervention can be. When the selected outcomes are different from trial to trial, it becomes much more challenging to reach a conclusion. Stuart Nicholls of the Ottawa Hospital Research Institute advocates core outcome sets as the remedy.

 
 
 
 
     
Four Milestones On The Path To Neurological Cell Therapy
 
 

How did we arrive at neurological cell therapy solutions? Dr. Ole Isacson explores the stem cell steppingstones — from blood transfusions to Parkinson’s disease treatments.

 
     
Tips For Overcoming Today's Drug Supply Challenges Through Technology
 
 

Better manage a supply chain through IRT with self-service tools, actionable insights, and best practices for supply forecasting and overstock management.

 
     
Improving TMF Management In Clinical Trials
 
 

Elevate your knowledge of clinical trials and the trial master file by exploring three critical topics with industry experts Rob Jones and Jacki Petty.

 
     
Navigating The 4 Critical Stages Of Drug Development
 
 

Get an overview of the critical planning activities and milestones in the drug development process and which important regulatory considerations should be taken at each stage.

 
     
Ultra-Deep Sequencing Data From A Liquid Biopsy Proficiency Study
 
 

Learn why it’s critical to understand the analytical validity and technical limitations of circulating tumor DNA sequencing in precision oncology.

 
     
Imaging In Clinical Trials: Pitfalls And Promises
 
 

Learn how experts apply imaging science and operational expertise to identify and manage the inherent risks to capturing complete and high-quality central review data of study endpoints.

 
     
Setting Up Your First-In-Human Clinical Trial For Success
 
 

For small or large molecules, simple or complex trials, Altasciences has the expertise, purpose-built Phase 1 facilities, and seamless processes to deliver quality with speed and ease.

 
     
Cell And Gene Market Outlook Shows Growth
 
 

Read for a closer look at the findings in ISR's Cell & Gene Therapies Market Outlook report, which offers some insight into the expanding cell and gene therapy field for innovators and manufacturers.

 
     
     
 
Events
 
Elevate Live Spring Series
 

May 2, 2023 - Cambridge, MA  |  11:30 a.m. – 4:30 p.m. EST
May 3, 2023 - Morristown, NJ  |  11:30 a.m. – 4:30 p.m. EST

Join Phlexglobal, a Pharmalex Company, for its Elevate Live Spring Series. During these two complimentary seminars, attending participants will learn how to elevate trial master file management, reduce inspection risk, and solve TMF challenges.

 
 
     
 
Choose Your Own Adventure
 
 

You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. 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.