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 it being "verbal" in nature. Verbal here simply m...

Stark law restricts the physician from referring patient to a designated place where he or his family members has a financial relationship unless an exception is met. It is intended to eliminate finan...

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 ownership and full protection for your idea. The ma...

Being a project manager for a matrix organization can be a lot more challenging and requires more communication and organizational skills, but ultimately it can be more rewarding. There is another pro...

I think that even in a project based organization, they can still make efforts to collaborate between departments. For example, there can be monthly presentations given by a member of one team to all ...

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 communicate with each other and can transfer knowledge abou...

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 companies that don't set out a timeline or set clear g...

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 devices, it would be interesting to study and rev...

From my experience in clinical research, one such document required by the FDA is an IRB, Institutional Review Board. This document is necessary to protect the welfare and rights of human subjects by ...

In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, "red knob"), whereas the DSD is design specification and gives a very spec...

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

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 recalls on the product which results in a large loss ...

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 offer no potential harm to any subjects, and this is...

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. It is used to prevent research outcomes from being ...

I would like the role of CQA - clinical quality assurance. CQA inspects the documents and processes clinical trial data and ensures that testing follows proper guidelines as stated by good clinical pr...