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aq49
@aq49
Eminent Member
Joined: Sep 8, 2024
Last seen: Dec 5, 2024
Topics: 0 / Replies: 39
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RE: Multi center xlinical teials and difficulties faced

Multi-center trials definitely bring unique challenges, especially around maintaining consistency across sites. I agree that clear communication and s...

2 months ago
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RE: Patient safety and data integrity during clinical trials

Patient safety and data integrity are at the heart of clinical trials, and guidelines like ICH and GCP provide a framework to ensure both. These stand...

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

Patient recruitment is a big hurdle in clinical trials, often causing delays and impacting study timelines. CRAs and CROs tackle this by using diverse...

2 months ago
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RE: How Sales and Marketing Works

These replies are great, and i’d also add that alignment between sales and marketing is key - when both teams collaborate effectively, the customer ex...

2 months ago
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RE: marketing strategies and technology

These are all great points, and I would add that medical device marketing also needs to focus on transparency and education. With technology evolving ...

2 months ago
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RE: Company Mission Statement

If I were to create a company, it would focus on developing sustainable healthcare technologies, specifically affordable diagnostic devices for unders...

2 months ago
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RE: S or C Corperation

Both structures definitely have their pros and cons, and I think the choice really comes down to the business’s growth plans and funding needs. For sm...

2 months ago
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RE: For New Business Builders

These are all great points, and I’d also add that building strong relationships with customers, vendors, and partners plays a key role in long-term su...

2 months ago
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RE: LLP vs LLC

These are great points. I’d just add that LLCs are usually the go-to for entrepreneurs because of their simplicity and flexibility, especially for ow...

2 months ago
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RE: The Quality Unit

Regulatory Affairs is an interesting field, and while I haven’t worked in it myself, I know that it plays a vital role in bridging the gap between com...

3 months ago
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RE: QA/QC Audits

I agree that audits, both internal and external, play a crucial role in ensuring that QA and QC follow proper protocols. It"s interesting how QA is ob...

3 months ago
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RE: FDA Advisory Panel Members with QC/QA Background

These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products....

3 months ago
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RE: Regulatory Basics

These are good points about post-market surveillance and the UDI system. I agree that regulatory compliance doesn't stop at FDA approval- it's an ongo...

3 months ago
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RE: FDA biased?

I couldn't fully follow along with the most recent comment on this thread because it was pretty lengthy without any paragraph breaks. As for the other...

3 months ago
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RE: Balancing Innovation and Safety

These are great points about the FDA’s challenge of balancing safety with innovation, especially when it comes to combination products. The blurred li...

3 months ago
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