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 […]
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. […]
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. […]
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 […]
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 […]
Executives and stakeholders in a drug development process are interested in two main things – seeing the overview of progress and having access to the budgetary data. Execs and stakeholders need this information to reduce risk during this lengthy process. If headway of the drug development process is stalled, halted or changes in any way […]
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 […]
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 […]
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. […]
There are tremendous risks associated when developing a new drug. Ordinarily a drug lifecycle is between 10-12 years and teams are bound to encounter unforeseen hurdles. If teams are not utilizing the same processes and tracking their progress in the same way that can result in unforeseen delays and loss of data. It is critical […]