Author Archives: DLTA

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 […]

Creating the Collaborative Team through Enterprise Work Management

The overall success of a team depends on whether it functions as a whole. A collaborative team works together and communicates. Transparency of work lends itself to communication among team members and across teams. Communication should span from the CEO, to top executives, to lower ranks of employees. With transparency, nothing will be missed. Having […]

Eliminating-data-loss-by-reducing-risk

Many hands go into developing a new drug and it is over the course of several years. As a result, data winds up getting lost or work is duplicated. For pharmaceuticals and CROs, internal processes can be a challenge with information scattered among various divisions each with separate tracking systems. Developing a new drug and […]

Reducing Risk Through Enterprise Work Management

Bringing a new drug to market is not without risk. Certainly every pharmaceutical has completed rigorous analysis and determined acceptable risk tolerances for everything, from adverse events to re-submission delays. Even still, it is nerve racking making the decision to initiate new drug development research given the lengthy timelines and costs associated with a drug. […]