Newsletter | November 16, 2022

11.16.22 -- Digital Solutions Top List of Life Science Trends

 
 
 
 
 
 

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)
 
 
     
 
Trial Management
     
Key Learnings To Optimize Clinical Trials During COVID-19
 
 

Designing and conducting trials during the COVID-19 global pandemic forced clinical teams to be creative, to explore the use of technology, and to design a trial that meets the participants where they are — without compromising outcomes. 

 
 
 
 
     
Smart Packaging In Clinical Trials: The Power Of Adherence Data
 
 

Individual data points over time can provide precise drug dosing histories that enable better understanding of protocol adherence, safety, efficacy, PK/PD, and a drug’s exposure-response relationship.

 
     
Tips For Overcoming Today's Drug Supply Challenges Through Technology
 
 

In this webinar, explore how to manage a supply chain through IRT with self-service tools and actionable insights as well as best practices for supply forecasting and overstock management.

 
     
Natural History Studies: Understanding Their Value In Rare Diseases
 
 

Registry and natural history studies can be very important to the clinical development of therapeutics in rare diseases. To accommodate these advances in knowledge, study design flexibility is a must.

 
     
Plain Language Summary Of Clinical Trial Results: A Critical Tool
 
 

This checklist will help guide your PLS development strategy and maximize team efficiencies to create a robust, long-term workflow that works for you and meets your timelines. 

 
     
The Basics Of A Clinical Trial
 
 

This blog reviews the basics of a clinical trial: what they are, where they fit in the wider drug development sequence, and all the things that go into them.

 
     
The ABCs Of Transitioning PK Assays From Preclinical To Clinical
 
 

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse.

 
     
Who Needs Clinical Supply Chain Management Optimization
 
 

While sponsors rely on efficient study design, planning, and execution to get their products to market, discover how logistical challenges almost always make it difficult to ensure that sites are prepared for their patients.

 
     
Dedicated Expertise In Your Fight Against Blood Cancers
 
 

At IQVIA Biotech, our extensive oncology expertise, coupled with the ability to leverage IQVIA’s vast data, technology, and analytics resources, creates a clinical development partner perfect for you. You want to get your treatments to the right patients.

 
     
PCI Clinical Trial Services
 
 

PCI is committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively. We deliver a seamless clinical service including pharmaceutical development, clinical manufacturing, labeling, storage, and distribution.

 
     
     
 
  Sponsor  
 
 
 
Webinar: Optimizing Clinical Supply Chain Management
 

The complexity of today’s clinical trials creates logistical challenges for clinical operations teams that result in a variety of problems. In this webinar, clinical operations teams, project managers, and clinical research coordinators will learn best practices to optimize clinical supply chain management. Click here to learn more.

 
 
 
     
 
Decentralized Trials
     
Digital Solutions, Technology, And Patient Care Top Life Sciences Trends
 
 

Technology company Within3 has produced a paper on the six top trends that are going to impact the pharmaceutical space. It’s no surprise that technology solutions were one of the trends making the list, but also included were factors such as patients, cyberthreats, and a growing global marketplace.

 
 
 
 
     
Understanding And Defining Technology Elements Of Decentralized Trials
 
 

The Decentralized Trials & Research Alliance (DTRA) has released a glossary defining many of the commonly used terms in the decentralized clinical research space. The FDA continues to release updated guidelines and recommendations for best practices and terminologies within the DCT industry. 

 
     
Enhance Decentralized Clinical Trials For Rare Disease Patients
 
 

Learn about the importance of enhancing decentralized clinical trial design, planning, and implementation for rare disease patients to ensure these patients and families find answers to unlocking that next gateway in their journey to health.

 
     
DCT Is Not The Goal, Just The Means
 
 

Learn more about the role of DCTs with a deep dive into an oncology case study as well as a pediatric case study, discussing the role of flexibility to support the DCT format.

 
     
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.

 
     
Applying Consumer Engagement Strategies To eClinical Technology
 
 

When it comes to patient engagement, the experience and technology gaps apparent in the clinical trial space have resulted in a lag for virtual technologies that offer comparable functionality to those pioneered by other sectors.