Newsletter | October 28, 2022

10.28.22 -- Risked-Based Oversight In Trials: What It Is (And Is Not)

 
 
 
 
 
 

Welcome to the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial MonitoringUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • 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
     
The EU (536/2014) CTIS Database Has Been Approved: What Happens Now?
 
 

In January 2022, EU (536/2014), a binding regulation across all members of the EU, came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

 
 
 
 
     
Humans And Artificial Intelligence Unite
 
 

In this white paper, discover how medical information organizations are redefining how people and AI can work together to rapidly respond to the surge in customer requests.

 
     
Heart Failure Indication Guide
 
 

Heart failure patients suffer a range of symptoms that negatively affect their quality of life. Learn how digital health technologies present an opportunity to track patient-centric outcomes.

 
     
Automated Data Capture To Train An AI Algorithm With eSource
 
 

Explore why an AI algorithm needs a steady and significant stream of data to become more accurate and prove its efficacy in a clinical setting.

 
     
How Can Sponsors And CROs Complete SDTM Activities With Increased Speed, Lower Costs, And Higher Accuracy?
 
 

How can sponsors ensure SDTM compliance while still maintaining the efficiency and speed necessary to meet their trial timelines and milestones? Find out in this article.

 
     
Secure Document Exchange
 
 

Developed in collaboration with Advarra’s Site-Sponsor Consortium, Secure Document Exchange (SDE) removes site burden by seamlessly integrating site and sponsor regulatory workflows.

 
     
Key Data Management Capabilities To Expect In A Strong eCOA Partner
 
 

Benefit from Kayentis’ data management culture for all your clinical studies and consider data management at each step of your study.

 
     
DIY Study Build At 2X The Speed
 
 

OpenClinica gives data managers the best of both worlds: exceptional capabilities and the ability for today’s clinical data managers to deploy them in their studies.

 
     
     
 
Trial Monitoring
     
What Risk-Based Oversight Of GxP Vendors Is And Is Not In Clinical Trials
 
 

Some pharmaceutical companies still have a notion that delegating responsibility for a clinical trial to a vendor is a way to transfer risks related to the delegated duties and functions. Nothing is further from the truth. This article examines what is vendor oversight in the context of ICH's GCP (R2) guideline.

 
 
 
 
     
Maximizing Site Enrollment With Better Protocol Comprehension
 
 

Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process: the investigative sites that implement the trials and interact with the patients throughout the process.

 
     
Leveraging Mobile Research Nurses For Clinical Trial Success In Vulnerable Patient Populations
 
 

Dr. Steven Cummings highlights the role of PCM Trials certified mobile research nurses in making possible large-scale home-based clinical trials.