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shreya
@shreya
Eminent Member
Joined: Sep 9, 2025
Last seen: Nov 30, 2025
Topics: 0 / Replies: 36
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RE: Patient safety and data integrity during clinical trials

One thing I’d add is that CRAs help maintain safety and data integrity not just through monitoring, but through ongoing site training and communicatio...

1 month ago
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RE: Challenges faced in patient recruitment, how can CROs and CRAs address them?

I think digital tools and AI are helping find eligible patients faster, but one challenge that still gets overlooked is the actual burden of participa...

1 month ago
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RE: Biomedical Engineers role in Clinical Research

I feel like biomedical engineers play a more active role in clinical research rather than just a supportive one. Yes, they help design devices and ana...

1 month ago
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RE: Market growth rate

Dexcom is another company that has been doing great and growing. It’s a business known for its continuous glucose monitoring (CGM) devices, and has ha...

2 months ago
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RE: Science and Strategy… or Just Storytelling?

I think your description of it as "serious science meets stand-up comedy" is really accurate. Especially for those who are not very knowledgeable abou...

2 months ago
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RE: Marketing Strategies to Differentiate from the Competition

Differentiation can rely less on the product itself in a time where many devices have similar features/functions and more on how businesses use patien...

2 months ago
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RE: Which Type of Business Structure Is Best for a Startup?

Your explanation of the transition from LLC to S-Corp to C-Corp is great; it makes a lot of sense, particularly for a business in the medical equipmen...

2 months ago
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RE: Why Is Cash Flow More Important Than Profit for a Business?

I agree that cash flow, which indicates a company's capacity to continue operating on a daily basis, is frequently more significant than profit. The i...

2 months ago
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RE: Public or Private: Which Path Builds a Stronger Company?

Although I agree that each ownership structure has advantages, I find it interesting how a company's innovation strategy and risk tolerance can vary d...

2 months ago
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RE: Punishment for Failing FDA Audits

One angle I think hasn’t been mentioned yet is how minor errors can actually reveal the “compliance culture” of a company. Even if labeling or paperwo...

2 months ago
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RE: Are Regulations Helping Innovation or Slowing It Down?

You both raise great arguments regarding how, depending on the company's resources, the FDA can either encourage or impede innovation. I agree that fu...

2 months ago
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RE: How to start career in regulatory area (no industry exp yet)

I get what you mean about regulatory sounding repetitive, but I think there’s more to it than just paperwork. If a company wants to sell in different ...

2 months ago
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RE: The Advantages and Disadvantages of Being Overqualified

I agree that being overqualified can open doors for promotions or leadership opportunities, but I think one challenge that doesn’t get mentioned enoug...

2 months ago
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RE: Bridging Design Innovation with Regulatory Compliance in Early Stages of Device Development

One aspect that is sometimes disregarded in my opinion, is how rules can sometimes really influence innovation rather than only restrict it. Human fac...

2 months ago
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RE: Key factors to consider while selecting appropriate animal models for pre-clinical research to develop therapies for neurological disorders.

I agree that species similarity and ethical considerations are central, but I think another key factor is how well an animal model can replicate not j...

2 months ago
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