A critical thing to note about a verbal agreement is that it often comes with a paper trail and can have many forms of evidence to back it up, despite...

Stark law restricts the physician from referring patient to a designated place where he or his family members has a financial relationship unless an e...

NDA only gives you protection from the individual in the contract, in which they promise to keep the idea confidential. A patent grants you proof of o...

Being a project manager for a matrix organization can be a lot more challenging and requires more communication and organizational skills, but ultimat...

I think that even in a project based organization, they can still make efforts to collaborate between departments. For example, there can be monthly p...

My ideal type of company to work for would be a matrix organization. I think it is beneficial to the company's productivity that departments communica...

A Gantt chart is essential for staying on track and getting the project done in a timely manner. I can tell you from experience that working with comp...

When design controls are not set up properly, it results in a failed medical device as stated by those examples above. In the case of recalled medical...

From my experience in clinical research, one such document required by the FDA is an IRB, Institutional Review Board. This document is necessary to pr...

Design transfer involves transitioning the design from planning stages to production. This is a critical trade-off that requires a few things in order...

Yes I agree that design control is an integral process and its failure can have a wide effect. If not done properly, the company will have to make rec...

I think it is very complicated to get IRB approval for a clinical trial where the outcome is unknown. The IRB wants to make sure that a device will of...

I think it depends on the study matter and double blind is not always necessary. Yet there are certain cases where double blind would be preferable. I...

I would like the role of CQA - clinical quality assurance. CQA inspects the documents and processes clinical trial data and ensures that testing follo...