Newsletter | December 7, 2022

12.07.22 -- Clinical Trial Study Planning, Management, And Optimization

 
The Clinical Development Plan: Ensuring Success
 

Developing a clinical development plan (CDP) takes time and effort, but is ultimately a key part of the navigation system — “the GPS” — to bringing an investigational medicinal product (IMP) to market. This white paper highlights key components for developing and executing a clinical research strategy.

Steps To Implementing A Quality Management System (QMS)
 

Read how science and research-driven activities require a high degree of flexibility and may demand fast reviews during the development stages and, at times, even reconsideration of the development program or project termination.

Reporting To The IRB: What Does And Does Not Need To Be Reported
 

An institutional review board’s (IRB’s) role in clinical research is to protect the rights and welfare of human subjects enrolled in a study. Delve into the IRB reporting requirements and learn why this type of reporting is important.

 
The Clinical Research Training Program Checklist: What To Look For
 

Despite their potential impact on a study’s success, training programs are often outdated, unengaging, and redundant. Therefore, it is critical to select a vendor or program encompassing not only regulatory requirements, but also your organization’s goals.

Beginner’s Guide To Clinical Trial Management Systems
 

The days of using spreadsheets to track are thankfully over for most sites. Discover how research centers can configure a clinical trial management system (CTMS) to bring powerful efficiencies insights and compliance to their day-to-day operations.

Solutions
Study Start-Up Support

As a key element of study start-up, 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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