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am458
@am458
Eminent Member
Joined: Sep 2, 2025
Last seen: Nov 30, 2025
Topics: 0 / Replies: 39
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RE: Gold Standard or Paperwork Nightmare?

I agree that Good Clinical Practice (GCP) is essential for maintaining ethical standards and protecting patients, but I also see how it can sometimes ...

1 month ago
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RE: Double Blind Vs Single blind Study

You raise a really good point — it does seem at first that a single-blind study, where only the patient doesn’t know what they’re receiving, should be...

1 month ago
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RE: Placebo Effect

The placebo effect is a fascinating and challenging aspect of clinical research because it highlights how powerful the mind-body connection can be. Wh...

1 month ago
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RE: Transition from Engineering to sales or marketing?

If I were to transition from an engineering role, I would likely choose marketing over sales, particularly in an upstream capacity. Marketing allows f...

2 months ago
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RE: Importance of brand storytelling in sales and marketing strategies

Storytelling is a powerful marketing strategy because it helps brands connect with customers on an emotional level and stand out in competitive market...

2 months ago
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RE: Long-term customer relationships in the face of increasing competition

I fully agree that securing a sale represents only a portion of the overall challenge; sustaining long-term relationships with customers is what truly...

2 months ago
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RE: Types of Corporations

I would want to be the owner of a Limited Liability Company (LLC) because it provides an excellent blend of legal protection, operational freedom, and...

2 months ago
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RE: MBA/ Business degree for Engineers

You raise an excellent point, which many technically qualified people encounter while pursuing entrepreneurship. I believe that engineers and scientis...

2 months ago
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RE: Public vs. Private

You make an important argument regarding the tradeoffs between public accountability and private freedom. I think that becoming private allows a firm ...

2 months ago
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RE: What are some ways Document Control can improve?

I believe the friction you identify is quite common—quality teams prioritize compliance and safety, whereas production and R&D prioritize speed an...

2 months ago
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RE: Discussion Topic: Quality Assurance vs. Quality Control

QA and QC do overlap because they both focus on product quality, but the skill sets and career pathways can be quite distinct. QA is primarily about s...

2 months ago
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RE: What’s the Real Difference Between Quality Control and Quality Assurance?

Great point! You're correct that QA and QC are frequently confused, yet they serve distinct roles. In the long term, I believe QA makes the greatest b...

2 months ago
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RE: FDA rules too strict?

The FDA's mission statement reflects a twin responsibility: to ensure the safety and efficacy of pharmaceuticals and devices while simultaneously enco...

2 months ago
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RE: Discussion Topic: The de Novo 510(k) Process

The De Novo 510(k) pathway is a regulatory procedure created by the FDA for innovative medical devices that are low to moderate risk but lack a lawful...

2 months ago
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RE: Role of clinical trials for medical devices & pharmaceuticals

Clinical trials are an important part of the medical device clearance process, but their aim and standards are very different from those for medicines...

2 months ago
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