SMOs and the Rapidly Changing Clinical Trial Environment

Posted by: DaVita Clinical Research

The pandemic ushered in a phase of rapid technological advancements across a number of business sectors, and clinical research was no different.

The tools that enabled everyday workers to easily video conference and transfer data remotely opened up a set of new capabilities for those of us in the world of clinical research. In the past, clinical studies could only take place in a few select locations, drawing from a limited pool of viable participants.

Now, clinical trials can take place almost anywhere there is internet access. This has dramatically expanded the pool of eligible participants. 

However, with these new capabilities have also come challenges. How do you effectively recruit and manage a trial population that could stretch across states or even countries, and how do you manage the sheer amount of data that studies can now produce?

Adapting to Regulatory Changes

The fact is, the clinical research sector is still grappling with how to most effectively — and ethically — manage the volume of data that clinical trials now produce. 

In late December 2021, the FDA issued draft guidance on the use of Digital Health Technologies (DHTs), an emerging tool for clinical trials that facilitate remote data collection. 

The FDA’s guidance recommends extensive new due diligence, including a thorough analysis of DHTs for risks before putting them into use. This includes evaluation of clinical risks associated with measurement error and cybersecurity threats, but also participant privacy-related risks. The objective is to maintain data integrity and limit unwanted data sharing.

Clinical research teams must now also design and implement renewed policies and processes for proper record retention and training to address technical, safety, privacy, and clinical data management risks with DHTs.

This guidance naturally introduces a significant amount of operational overhead in managing clinical research.

Unique Position of a SMO

This is where site management organizations such as DaVita Clinical Research are uniquely positioned to lead the way in this new clinical research environment.

SMOs offer regulatory and operational support services for clinical trials. They specialize in the management of clinical research, which offers a number of advantages versus managing your research via in-house teams.

With built-in access to a broad patient base and a focus on responsible data handling and regulatory compliance, SMOs like DaVita Clinical Research offer the capability for a faster startup and smoother administration as trials start. Contact us today for more information about DaVita® Clinical Trials and our site management services.