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Anthony
@anthony
Eminent Member
Joined: Jan 11, 2019
Topics: 2 / Replies: 32
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RE: Choosing a CRO

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...

6 years ago
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6 years ago
Replies: 4
Views: 1950
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RE: Discussion Topic: Outsource vs. Insource the clinical trial

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 hu...

6 years ago
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RE: Avoiding Tunnel Vision

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 t...

6 years ago
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RE: How was this class helpful

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...

6 years ago
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RE: Changining staff

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 ...

6 years ago
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RE: Specifications: A double edged sword?

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 sp...

6 years ago
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RE: Single Source/Dual Source

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 ...

6 years ago
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RE: Which of the following project would you say is better and why

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 proj...

6 years ago
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RE: Design Review Meetings

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 smal...

6 years ago
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RE: Monitoring and Controlling Phase

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 ...

6 years ago
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RE: Work Logs and FDA Audits

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 p...

6 years ago
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RE: Design Validation

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 ...

6 years ago
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RE: Unexpected Time Delays - miniSim

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 simul...

6 years ago
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RE: Problem with the Vendors

From our most recent lecture we learned that requesting seller responses and selecting vendors is part of directing and managing project execution. Du...

6 years ago
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