Last seen: Dec 5, 2024
Multi-center trials definitely bring unique challenges, especially around maintaining consistency across sites. I agree that clear communication and s...
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...
Patient recruitment is a big hurdle in clinical trials, often causing delays and impacting study timelines. CRAs and CROs tackle this by using diverse...
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...
These are all great points, and I would add that medical device marketing also needs to focus on transparency and education. With technology evolving ...
If I were to create a company, it would focus on developing sustainable healthcare technologies, specifically affordable diagnostic devices for unders...
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...
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...
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...
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...
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...
These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products....
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...
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...
These are great points about the FDA’s challenge of balancing safety with innovation, especially when it comes to combination products. The blurred li...