Protocol Review

Protocol development and study design has many moving parts and often requires the expertise across multiple disciplines in clinical research to understand how feasible a study may be with the resources and services available.

We’ve addressed the need for a streamlined workflow in applying for clinical research resources previously with a custom application, Protocol Review. This home-grown application was created by first understanding the needs of the clinical research staff at three Harvard affiliates, whose individual standard operating procedures represented a decent sample of the larger clinical research community.

What we learned from developing this application was how important fine-grained roles and responsibilities were to the success of a tool for protocol development. As the document workflow application market matured, it became clear that transitioning to a mature platform was highly desirable.

After assessing the landscape of applications that could achieve our goals, we partnered with Huron Consulting to leverage their Click Portal upon which we rebuilt the workflow of our retired home-grown solution, Protocol Review.

Using a platform to provide a tool to our users highlighted for us how important our user’s understanding of their study design methods are to the success of investigators seeking resources.