Newsletter | February 10, 2023

02.10.23 -- The 5Vs Of Collecting Clinical Data

 
     
 
     
 
 
 

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 & Analysis
     
The 5Vs Of Collecting Clinical Data
 
 

Not all data is created equal. Our data strategies need to be commensurate with the risks, complexity, and value of the data collected. If the true value of data is to be realized, it must be collected and captured in accordance with the five “V” dimensions: volume, variety, velocity, veracity, and value.

 
 
 
 
     
The Beginner’s Guide To An Electronic Data Capture (EDC) System
 
 

In this blog, delve into a basic understanding of the EDC system and its role in clinical trials.

 
     
6 Data Linkage Use Cases To Future-Proof Your Clinical Trial
 
 

Explore how connecting clinical trial data and real-world data can provide a fuller view of the patient journey and enhance evidence generation.

 
     
Get Your Queries Under Control (Part 1: Query Aging)
 
 

Data capture entries, when left unresolved, not only create more work for monitors and coordinators, but delay interim and final locks.

 
     
eCRF In Clinical Trials: Shifting To A Modern Research Paradigm
 
 

The technology researchers use to manage data collection for clinical trials has not kept pace with the industry’s rapid growth. Innovative software solutions and interoperability breakthroughs are out there, but the clinical research world has been slow to adapt.

 
     
Regulatory Approval For Novel Device Achieved With Comprehensive Clinical Data Management
 
 

Find out how data capture and management activities, programming, and medical writing for a clinical study report were supported to solve the major diagnostic challenge of distinguishing between bacterial and viral infections.

 
     
It's Time To Cut The Line: Repositioning Your CDM Team To Meet Digital Trial Demands
 
 
Instituting risk-based quality management (RBQM) and adjusting to the influx of direct-from-patient data requires data operations to decommission linear processes and adopt a holistic, agile approach that embraces data science and central monitoring.
 
     
Pharmaprojects By Citeline
 
 

With Pharmaprojects, leverage your mastery of the R&D space to create winning strategies, identify the right drugs to license, and support the key decisions that will drive your company forward.

 
     
Clinical One Data Collection: Beyond EDC
 
 

Every day, clinical trials are incorporating more virtual components, becoming more decentralized, and focusing on the patient. Clinical trial data is no longer limited to traditional form data. What if you had the ability to collect and manage all your clinical data in one place?

 
     
     
 
Trial Monitoring
     
The 4-Step Checklist For Small Biopharmas To Recruit And Retain Clinical Trial Managers
 
 

Talent shortage is causing a backlog in clinical studies. One position critical to helping ease this jam is clinical trial managers, who serve as the primary organizers and supervisors over the trial. If you work at a small biopharma company, this article is for you.

 
 
 
 
     
The 'Creativity Lane' Of Clinical Monitoring
 
 

Monitoring aspects of a clinical trial have been costly and very process-laden, but are we stuck forever with our current monitoring standards? Find out more in the first blog within this RBQM series.

 
     
Achieving And Maintaining Sponsor Oversight Of Outsourced Studies
 
 

Regulators have made it abundantly clear, through recent guidance and inspection findings, that compliance responsibility for an outsourced trial lies with the sponsor — and not the service provider.

 
     
elluminate® RBQM
 
 
elluminate RBQM provides clinical teams with a single platform for all study data sources to support a more focused, data-driven monitoring effort that enables active oversight and improves the compliance of a clinical trial.