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jrc99
@jrc99
Eminent Member
Joined: Jan 26, 2025
Last seen: Apr 21, 2025
Topics: 4 / Replies: 32
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RE: Balancing Cost, Time, and Quality in Clinical Trials

I think incorporating Risk-Based Monitoring could be an effective way to maintain study qualities without sacrificing cost and timeline goals. The ana...

2 days ago
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RE: Role of Communication Plans in Clinical Trial Execution

I have not come across a project where there was a lack of structured communication, but I think I have some thoughts on effective tools and strategie...

2 days ago
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RE: Protocol Deviations vs. Violations in Clinical Trials

I think keeping clear definitions of a deviation and a violation to all staff are necessary. Trained staff is better than untrained staff. Untrained s...

2 days ago
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RE: Human Resource Management

I think using Failure Mode and Effects Analysis (FMEA) can be an effective approach to prevent errors, losses, or subsequent issues. It is a tool risk...

4 days ago
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RE: Allergan's BIOCELL Breast Implant Recall: A Case Study in Quality and Risk Management

I think it is very important to bring up these past situations so the future generations can continue to learn to avoid such disasters. In medical dev...

1 week ago
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RE: Cost Estimating – Choosing Between Speed and Accuracy

I definitely agree with the last post that using a hybrid method using both analogous and bottom-up estimation methods is an effective approach. I thi...

1 week ago
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RE: Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical

I think that cases like these really highlight how project development errors can affect stakeholders so strongly. Many parties will suffer because of...

2 weeks ago
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RE: Navigating the Risks of Post-Verification Changes

As the last post mentions, FMEA is a great and effective decision-making framework to use in such a scenario. It is extremely effective because it pre...

2 weeks ago
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RE: Managing Early Market Interest Before Project Completion

I think the aspect of sharing unfinished designs can be improved. Even though sharing a successful idea can boost the morale of the team, it can be ju...

2 weeks ago
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RE: Managing Challenges in Metrics

I think a way project teams ensure that they measure relevant metrics is to focus on measurements pertaining to regulatory demands, validation and ver...

4 weeks ago
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RE: Role of Monitoring & Controlling in Project Success

Using the information about EV, PV, and AC, I think could pose a risk if it is not paired with any other form of analysis. EV, PV, and AC are surface ...

1 month ago
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RE: Change Control in Project Management

Organizations can strike the right balance between maintaining control and allowing flexibility for creative problem-solving and adaptation by incorpo...

1 month ago
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RE: Optimizing Information Distribution

I think a great approach to fix the potential problems from each extreme side is to incorporate two ways of communicating informational updates. For i...

1 month ago
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RE: Information Distribution For Project Success

I think project managers can strike the right balance between providing enough information without overwhelming stakeholders through two methods. The ...

1 month ago
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RE: Significance of Scope Verification in Project Execution

I think the biggest challenges in achieving scope verification are managing the communications between all team members and stakeholders in the projec...

1 month ago
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