Newsletter | February 15, 2023

02.15.23 -- Applying Agile Methodologies To Phase 2 Trials

 
     
 
     
 
  Sponsor  
     
 
Webinar: Everything You Need To Know About Adopting eConsent Across Large Pharma Organizations
 

Join Camila Matheny, DCT implementation expert, as she discusses the benefits of adopting consent management technology and provides best practices around developing change management and training programs to help sponsors, CROs, and sites get the most out of eConsent. Click here to learn more.

 
 
 
 
 
 
     
 
Decentralized Trials
     
How Is The Role Of Clinical Data Manager Changing?
 
 

The results of a study are only as good as the data collected. For that reason, clinical data managers (CDMs) are often the unsung heroes of clinical trials. Those managers must ensure the collected data is accurate while avoiding tainted data that can endanger patients, studies, and the reputations of the companies conducting the research.

 
 
 
 
     
What Does "Good" Look Like In A Decentralized Clinical Trial?
 
 

Delve into the answer to the question: What is the right way to perform decentralized trials in order that they can be controlled and managed effectively?

 
     
How Will COVID-Era Clinical Trial Changes Affect Future Research?
 
 

Driven by necessity, the life sciences industry rapidly shifted to decentralized methods of clinical trial research during the COVID-19 pandemic. Will these changes remain, and, if so, what does this mean for the future of clinical trials?

 
     
Switching To Direct-To-Patient Rapidly In The EU
 
 

Explore the logistical risk management factors to consider when deciding to switch to direct-to-patient shipments in the EU.

 
     
     
 
Trial Management
     
Embracing Agility In Phase 2 Clinical Trials
 
 

Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.

 
 
 
 
     
Top 3 Reasons Why A Direct-To-Patient Clinical Trial Is Right For You
 
 

As the focus on precision and personalized medicine continues to increase, the direct-to-patient (DTP) model has emerged as a potential solution. Discover the top three challenges many sponsors face, and how a direct-to-patient pharmacy can provide solutions.

 
     
First-In-Human Solution For Small And Large Molecules
 
 

Small or large molecules, simple or complex trials; discover how expertise, purpose-built facilities, and seamless processes can deliver quality with speed and ease.

 
     
The Workflow Of Medicare Coverage Analysis
 
 

Explore a step-by-step process to determine whether your clinical trial meets the requirements of the national coverage determination (NCD) for routine costs in clinical trials.

 
     
Next-Generation Drug Development Strategies
 
 

From screening master protocols to the use of data science and artificial intelligence (AI), how can biotech companies achieve the best patient outcomes? Gain insight into three considerations for companies when planning drug development strategies.

 
     
Regenerative Medicine Development: Challenges And Key Success Factors For Rapid Approval
 
 

The global regenerative medicine market anticipates expanding remarkably due to advancements in technology and growing applications for the treatment of chronic diseases. Listen as regulatory, non-clinical, and clinical experts share current challenges and provide key factors for success.

 
     
TMF Risk-Based Quality Control: What Does This Really Mean?
 
 

Trial master file (TMF) quality control is a topic that always seems to be present on conference agendas, and it invokes much discussion and debate. Learn how to best meet the requirements for effective quality control in a trial master file.

 
     
Does The 10,000-Hours Rule Apply To Clinical Trials?
 
 

How do you define clinical trial expertise and how can you identify expert providers? Look at the signs of clinical trial expertise and explain why those elements are critical to clinical trial success.

 
     
How To Design Your Next Diagnostic Study For Successful Execution And Efficiency
 
 

When it comes to designing diagnostic clinical trials that are modernized, efficient, executable, and cost-effective, explore why there is a strong need to think and plan beyond standard scientific design.

 
     
New Is Risky. Start With A Free Feasibility Report.
 
 

Get a free preliminary evaluation of your protocol design from a leading CRO in Eastern Europe.

 
     
Understanding Options In Direct-To-Patient Clinical Supply
 
 

Direct-to-patient clinical supply enables clinical trial participants to receive their treatments in the convenience and comfort of their own home and reduces, or even eliminates, the need to travel to a clinical site.

 
     
     
 
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.