Monthly Archives: June 2016

Regulatory Affairs Activities

The regulatory teams within an organization are a shared service group. As a shared group, their work schedule is dependent on the workflow of the internal teams they serve as well as the external site locations used by the clinical trial. The following case scenario illustrates the difficulty of monitoring progress by multiple teams.This scenario […]

Clinical Management

The following case scenario illustrates the difficulty Contract Research Organizations (CROs) and Pharmaceutical companies have when it comes to managing multiple people and teams involved in the clinical management phase of a drug lifecycle.This scenario is an example only, and is not meant to be a complete overview of the entire clinical research process. Scenario. […]

Clinical Management

The following case scenario illustrates the difficulty Contract Research Organizations (CROs) and Pharmaceutical companies have when it comes to managing multiple people and teams involved in the clinical management phase of a drug lifecycle.This scenario is an example only, and is not meant to be a complete overview of the entire clinical research process. Scenario. […]

Pre-Clinical Management Case Scenario

The following case scenario illustrates the complexity of the drug development process. Each step in the process noted below is numbered within parenthesis. This is a scenario only, and not meant to be a complete overview of the entire drug development process. Scenario. During a steering committee on a new drug, Greg Hammond, the drug […]

Pre-Clinical Management Case Scenario

The following case scenario illustrates the complexity of the drug development process. Each step in the process noted below is numbered within parenthesis. This is a scenario only, and not meant to be a complete overview of the entire drug development process. Scenario. During a steering committee on a new drug, Greg Hammond, the drug […]