Newsletter | November 4, 2022

11.04.22 -- How Can I Use RWD In My Clinical Trials?

 
 
 
 
 
 

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
     
How Can I Use Real-World Data In Clinical Trials?
 
 

Real-world data (RWD) and real-world evidence (RWE) can be relevant and essential to bringing innovation to patients and gaining regulatory approval. This article describes the sources of real-world data, how to use real-world data to enhance a development program, and how RWD and RWE advance regulatory decision-making.

 
 
 
 
     
Peer Advice: How One Clinical Data Manager Does More With Less
 
 

Clinical data managers sit at the intersection of busy information highways in clinical trials, but they do more than just direct traffic. Learn how their information can be managed in this Q&A with Justine Pierson, a battle-tested clinical data manager.

 
     
Medical Information Teams Embrace Artificial Intelligence
 
 

Global biopharma companies are constantly looking for ways to increase awareness and engage health care professionals (HCPs) seeking medical information. Explore why many see artificial intelligence (AI) as a big part of the solution.

 
     
Control Your Data Flow, Control Your Trial
 
 

The surge of healthcare data threatens to cripple healthcare organizations. But an effective data flow environment can get it under control.

 
     
The Annual Clinical Trials Roundup 2021
 
 

This year’s roundup focuses on Phase 1-3 clinical trials initiated in 2021 across all therapeutic areas. The significant growth in trials in 2021 results from approaches used in response to the pandemic, such as decentralized trials, innovative recruitment strategies, and greater patient engagement.

 
     
How Paper And Electronic Source Data Meet ALCOA-C Principles
 
 

According to the Food and Drug Administration (FDA), data should meet certain fundamental elements of quality. If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective. 

 
     
Enabling Personalized Medicine Through Big Data
 
 

While the term has been used more frequently in recent years, personalized medicine is not a new concept; healthcare professionals have been tailoring treatment to an individual’s specific needs since the advent of medicine.

 
     
The Future Of Real-World Evidence Generation
 
 

There are many different elements to complete and curve balls to dodge when taking a treatment/drug/device to market that require precision and accuracy. You need insights to make informed decisions during the discovery, development, and commercialization steps in the process.

 
     
Clinical Data Review Analytics Solution
 
 

The PerkinElmer Clinical Data Review Solution provides the most effective way to perform instream review of study data, empowering clinical development teams to make smarter decisions faster.

 
     
Bioforum JetConvert: SDTM Automation Platform
 
 

Bioforum's SDTM automation platform can save your organization time and money while providing critical new capabilities.

 
     
     
 
Trial Monitoring
     
What Is A Risk-Based Approach To CRO Oversight?
 
 

Ian Wyglendowski, head of strategic clinical partnering at UCB, recommends taking a risk-based approach to CRO oversight. The first step is understanding the risk that exists. If an inspector walked in today and asked how you, the sponsor, could ensure that an activity you have outsourced complies with ICH GCP regulations, would you know how to answer that question?

 
 
 
 
     
5 Reasons To Make The Move To Automated Safety Document Distribution
 
 

This webinar discusses current operation models in the world of safety document distribution and the modern approaches to reduce complexity and compliance risk, as well as increase efficiency.