ec52 and Sk90, thank you for your responses. The answers you've provided about CRO selection criteria, questions to ask when inquiring about them, and selecting at least three to evaluate are valuable...

Does partnering with a CRO reduce project risk? If you do choose to partner with a CRO how do you go about choosing the CRO? My initial thought was that hiring a CRO does indeed reduce risk, but then ...

I think outsourcing a clinical trial is the most efficient option for a medical device company. In my opinion I think that outsourcing will free up human resources for working on additional projects a...

Tunnel vision can lead to the downfall of a project because you may miss valuable information or indicators while focusing on a single task. I think the best way to avoid tunnel vision is to have an e...

I have gotten the most out of the simulations from this course. They teach you to not only think about a scientific or technical solution to a problem that may arise during a project, but to also thin...

If you are in a weak matrix organization then the functional heads may have more power than the project managers and may dictate who is allowed to be on your project team and for how long. These emplo...

I think that it may be a good idea to put the extra time into thinking about the specifications of a critical component. Yes you want them to be as specific as possible, but if you know during design ...

This is one of those situations where you would need to find the balance between your quality management plan and your risk management plan. You need to satisfy your quality requirements first and the...

In my opinion I think in a general sense it is better to have negative SV paired with a positive CV. My reasoning goes like this, if you are on a project that is behind schedule with a negative SV but...

No first hand experience here, but I'd have to agree with Ryan, the early stages of the project are the foundation for the future stages. Im sure small aspects can overlap or melt between two process ...

I don't have any first hand experience, but I do understand and agree with why a project should be tracked this way. Your planned value will create a target to aim for by a certain date, the earned va...

I have an example that was thankfully caught by internal QC before any other agency was aware. There was a situation in a diagnostic lab where a new processing technician (non-bench/wet lab position),...

The whole reason why medical devices, or products in general, are created are to fill a users need, and that need will be heavily researched prior to the initiation of the project, think back to the i...

I think that there are some cases where shortening the time frame of a study is a good option. Using the bone void filler syringes from the last simulation as an example, we needed to verify a two yea...

From our most recent lecture we learned that requesting seller responses and selecting vendors is part of directing and managing project execution. During this phase you are obtaining quotes from appr...