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shreya
@shreya
Trusted Member
Joined: Sep 9, 2025
Last seen: May 3, 2026
Topics: 0 / Replies: 69
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RE: How to manage contracts with external clinical trial management teams?

One idea I haven’t seen mentioned yet is the importance of building internal minimal oversight expertise even if the company outsources everything els...

2 weeks ago
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RE: Are you an X or Y?

I would lean toward choosing a Y-type employee, but not just because they’re more motivated, more because they tend to be more adaptable over time. In...

2 weeks ago
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RE: How much time/money should be invested into trying to make a cheaper vendor's product work?

One thing I haven’t seen mentioned yet is that this issue could have been avoided earlier if the team had set clear acceptance criteria for the pouche...

2 weeks ago
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RE: Methods to make a time and budget planning in the clinical trial

One aspect that hasn’t been discussed much is the use of scenario-based planning and simulation models in clinical trial design. Instead of relying on...

3 weeks ago
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RE: In case of recall

One aspect that hasn’t been discussed much is the role of post-market surveillance and real-world data analytics in preventing and managing recalls. I...

3 weeks ago
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RE: Broadening the test groups in clinical trials

One additional approach could be using decentralized or hybrid clinical trials, where some parts of the study (like follow-ups or monitoring) are done...

3 weeks ago
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RE: Project Cost Management : Top-Down vs Bottom-Up

I think your point about budgets acting as a negotiation tool early on is really interesting, and it raises an important question about whether budget...

4 weeks ago
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RE: Navigating unknown project budgets

I really like the focus on prioritization and balancing compliance vs. discretionary changes. One additional angle that could help with unknown budget...

4 weeks ago
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RE: Complications with Management Sectors

I really like the points raised about assumptions and knowledge transfer. One additional challenge I think isn’t talked about as much is decision late...

4 weeks ago
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RE: Scope Management in Biomedical Devices

One thing I think is really helpful is breaking requirements into must-have vs nice-to-have. In biomedical projects, especially during something like ...

1 month ago
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RE: Tools and techniques in project management

One aspect that hasn’t been discussed much is how project management tools support regulatory decision-making and traceability, which is important in ...

1 month ago
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RE: project changes and stakeholders

One approach that hasn’t been discussed yet is using a visual impact assessment, such as a simple impact matrix or dashboard, to quickly show how a pr...

1 month ago
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RE: The power of the board of directors

I agree that the board of directors mainly operates at a high level and is not involved in day-to-day project execution, but one aspect that stood out...

2 months ago
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RE: Monitoring and Controlling Process

I like the points about traceability and feedback loops, but one thing I think is also important is the use of real-time monitoring dashboards and lea...

2 months ago
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RE: Project Delays and Returning to Schedule

I agree with the idea of building buffer time and finding alternative paths, but one thing I think is really important that hasn’t been emphasized as ...

2 months ago
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