Newsletter | December 7, 2022

12.07.22 -- What Astellas Learned About Decentralized Trials

 
     
 
     
 
 
 

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)
 
 
     
 
  Virtual Event  
 
 
 
Webinar: Hard-Earned Lessons From Clinical Trial Implementations
 

How can companies implement new clinical software and technologies more effectively? And how can they avoid common pitfalls? Join Clinical Leader Live as we feature a panel of experts to share their insights, best practices, and real-world examples of what has and hasn’t worked. This event is free to attend thanks to the support of Medrio.

 
 
 
     
 
Decentralized Trials
     
What Astellas Has Learned About Decentralized Trials
 
 

When the COVID-19 pandemic hit in the spring of 2020, many companies were unprepared for the changes that were about to impact their studies. Astellas is one company that was better prepared than most. The company had initiated a formalized, internal project on decentralized clinical trial (DCT) technologies and their use in clinical trials about nine months prior to the pandemic.

 
 
 
 
     
Enhancing Clinical Trial Accessibility: Bringing Oncology Trials To Patients
 
 

Today, proactively incorporating community clinicians and sites into clinical research is the next step in broadening the reach and diversity of oncology studies while still generating high-quality data. Listen to this podcast to find out more.

 
     
Considerations For The Implementation Of Successful Decentralized Trials
 
 

Learn how hybrid and decentralized clinical trials can provide patients the opportunity to participate in a clinical trial and receive a treatment to which they would otherwise not have access.

 
     
Decentralized Clinical Trials Help With Patient Recruitment And Retention
 
 

For sponsors, discover how decentralized trials (DCTs) show promise for boosting recruitment and helping subject retention.

 
     
Self-Collection Safety Liver Panel
 
 

Clinical trials are becoming increasingly decentralized, and Q² Solutions is committed to discovering innovative ways of improving the patient and investigator experience.

 
     
PCM Trials Is A Preferred Provider Of Mobile Clinical Research
 
 

When you consider the criteria that are most important to your trial success, PCM Trials comes out as a preferred choice time and time again. Why?

 
     
     
 
Trial Management
     
A Firsthand Experience In Africa: Sub-Sahara Has A Lot To Offer
 
 

In “Better Than Expected — A Firsthand Experience In Africa,” Kamila Novak shared her positive impressions from visiting medical research centers in sub-Saharan Africa. However, the picture would not be complete without talking about the continent’s personal safety and professional security, regulatory landscape, and ongoing socioeconomic challenges.

 

 
 
 
 
     
Reimbursement Removes Financial Toxicity From Oncology Clinical Trials
 
 

Learn what sites, CROs, and patient advocacy groups are doing to make clinical trials accessible to the most at-risk patients and the solutions that can maximize diverse clinical trial enrollment.

 
     
Nephrology Patient Safety Starts In The Clinical Trial Setting
 
 

Is the clinical trial setting the best environment to ensure a patient’s safety? Dr. Jamie P. Dwyer discusses how nephrology clinical trials identify future patient risk factors for medication and treatment in the real-world setting.

 
     
An Interview With Dr. Albert Kim On Simulation-Guided Design
 
 

In the following interview, Cytel’s chief medical officer, Dr. Albert Kim, speaks with Dr. Esha Senchaudhuri to discuss many aspects of simulation-guided design – its abilities, its benefits, and so much more.   

 
     
Clinical Supply Distribution Strategy: Planning And Adapting
 
 

Discover how to ensure your distribution plan is robust, how to best determine your depot requirements, how to efficiently adapt to study changes, as well as how COVID-19 may impact your distribution planning.

 
     
Setting Yourself Up For Success During Investigator-Initiated Trials
 
 

An IIT is a result of an investigator creating an idea for a study, developing the protocol, and serving as both the sponsor and the investigator for the trial. Discover why there is much to plan in order for it to run smoothly.

 
     
How Clinical Trial Complexity Impacts End Users
 
 

This article examines clinical trial complexity through the lens of study investigators, site staff, CRAs, sponsor study and supply managers, and how the RTSM/IRT provides the ability to be as creative as needed.

 
     
The Role Of Data, Relationships, And Experience In Comparator Sourcing
 
 

Successfully sourcing commercial products for comparative studies in an effective and efficient manner often proves far more challenging than assumed.

 
     
Strategies For External Comparator Arms Leveraging Real-World Insights
 
 

This paper explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.

 
     
Desired Integrated Clinical Activities
 
 

In Q1 2022, ISR surveyed 100 sponsors who outsource clinical logistics and asked them which activities they would like to source from a single service provider for a trial. Learn why clinical labeling, clinical supply chain management, and storage and distribution of clinical trial materials received the most votes.

 
     
Comparator Local Sourcing Strategies: Avoiding Pitfalls For Clinical Trials
 
 

The growing demand for comparators is causing many supply chain managers to explore available sourcing options. Explore alternative local sourcing strategies, including advantages and disadvantages.

 
     
Harbor Clinical FSP Model: Functional, Flexible, Fractional
 
 

Harbor Clinical has redefined the FSP service model, adding enhanced flexibility in timing, scope, and level of resources assigned. 

 
     
Single-Source Supply Chain Solutions For Today’s Clinical Trial Ecosystem
 
 

Marken provides a best-in-class quality management system, a global GMP depot network, direct-to/from-patient, home healthcare nursing services, and industry-leading expertise all under one single-source provider

 
     
LabConnect's Scientific Operations Services
 
 

Today’s complex clinical trials require reliable and experienced technical and operational support throughout a study. Watch this video to see how LabConnect has supported their clients in critical functions by providing biospecimen managers and scientists to drive successful outcomes.

 
     
Clinical Trial Material Distribution Services
 
 

As your clinical material partner, we simplify – and accelerate – your clinical trials. From assistance with time-consuming international documentation through destruction following all regulatory protocols, RPS is your trusted clinical trial partner.