Newsletter | November 11, 2022

11.11.22 -- The Benefits Of An Optimized Study Startup

 
Beginner’s Guide To eTMF, eISF, And Regulatory Research Documents
 

This blog identifies applicable regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exchange, and store them.

Expedite Study Startup: Four Strategies To Optimize Site Activation
 

One of the few study timelines within the study team’s control is getting sites up and running more efficiently. Amid a million ways to go wrong, there are always opportunities to improve and optimize. This white paper will explore four strategies to execute across site selection, training, ethics review, and site initiation.  

Beginner’s Guide To Investigator-Initiated Trials
 

When an investigator has an idea for a study they’d like to conduct, they may begin what is known as an investigator-initiated trial, or IIT. In this article, explore a basic understanding of IITs and how they fit into the clinical research landscape.

Current State Of Trial Opportunity And Selection
 

From the time a sponsor decides to conduct a trial, they must make numerous decisions quickly to maximize the ability to bring new treatments to market in a timely and cost-effective manner. Gain insight into the site selection process sponsors undergo and the information sites provide as part of the site feasibility questionnaire completion.

A Checklist For Optimizing Clinical Trial Study Startup Activities
 

Learn how the solution to the key challenge of successful, timely study startup requires careful coordination across multiple constituencies outside and within a research organization.

Solutions
Study Startup Support

As a key element of study startup, IRB review can have a substantial impact on meeting critical study milestones. Advarra provides flexible solutions to help accelerate the initial IRB review process and make it more efficient.

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