Electronic informed consent (eConsent) tools are emerging as a valuable solution in the quest to deliver a more patient-centric clinical trial experience. eConsent platforms take the complex paper ...

The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...

This focus on “critical-to-quality” factors reflects a relatively new “quality by design” approach to clinical research, reflected in the ICH Guidance E8(R1) General Considerations for ...

A clinical research organization, A data safety monitor (e.g., DSMB, DSMC) An internal monitoring process. Participant Withdrawal from Research--Guidance for Investigators. When a participant ...

The use of core protocols can facilitate the implementation of clinical research across successive outbreaks. The PALM trial included a core-protocol framework to guard against the release of ...

NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company”), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic ...

Over the past decade, the cost of genome-scale sequencing (i.e., genome and exome sequencing) has dropped dramatically, which has led to its increased application in clinical and research settings ...

The growing adoption of RWD and RWE has been instrumental in making ECAs a viable option in clinical research. ... In my experience, a robust ECA requires a clear protocol and statistical plan.

The challenge: protocol amendments and the hinderances of paper informed consent . Protocol amendments are a common part of clinical trials, and yet they remain one of the most prominent causes of ...