Both of you raise excellent points. The project management triangle becomes especially complex in clinical trials because compromising on quality is not just a theoretical risk—it can have real ethical, financial, and regulatory consequences. I agree that Risk-Based Monitoring (RBM)…   Read more»

These are all excellent points, and I completely agree that a strong foundation of staff training and clear definitions is essential for managing protocol noncompliance effectively. I also think that one of the most impactful strategies is fostering a culture…   Read more»

If I’m leading a team in my medical device company, I’m maintaining a positive atmosphere and ensuring the objective is clear. To begin with, I would ensure that everyone understands their contributions truly count and give credit where it is…   Read more»

I believe that while job satisfaction is often glorified as the key to retaining your employees and promoting productivity, it is quite idealistic. In my experience, compensation frequently outweighs satisfaction, especially in high pressure fields. You can love your job…   Read more»

I believe that clinical trial teams can find a good balance between following the protocol and keeping patients safe by treating their given protocol as a flexible guide rather than a strict rulebook. I know this is not a conventional…   Read more»

That’s a really good point—you’re right that no one structure fits every situation. As a team leader, I believe the first step is to consider the nature of the project and the available resources. If the project is short-term and…   Read more»

Project managers and program managers may sound like they perform similar work, but their roles are actually quite different. A project manager focuses on a specific project with clear goals, deadlines, and deliverables. They are responsible for ensuring everything runs…   Read more»

That’s a really thoughtful question, and it highlights the core tension behind the HDE program—balancing access and safety. On one hand, the HDE has been a game-changer for patients with rare diseases who previously had no treatment options at all….   Read more»

You’re really close, and your explanation is solid—especially in distinguishing that verification asks “Did we build the product right?” while validation asks “Did we build the right product?” That distinction is at the heart of it. However, you’re also correct to question whether they…   Read more»

I completely agree with your perspective—treating the DDP as a living document is essential. In my view, one of the most effective ways for companies to achieve that balance is by implementing a robust change management process from the outset….   Read more»

That’s a great point, and it’s definitely a common challenge in many teams. One approach I’ve seen work well is tying the reporting process directly to team goals and making it part of the team’s culture rather than a top-down…   Read more»

I think incorporating Risk-Based Monitoring could be an effective way to maintain study qualities without sacrificing cost and timeline goals. The analytical data that RBM provides can identify points in clinical trials that pose the most risk. The risk at…   Read more»

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 strategies to remedy this. My first thought is to incorporate the RACI (Responsible, Accountable,…   Read more»

I think keeping clear definitions of a deviation and a violation to all staff are necessary. Trained staff is better than untrained staff. Untrained staff that may not be able to classify something as a violation correctly increases the chances…   Read more»

Building on the excellent points already raised, one additional strategy is to engage stakeholders early in protocol development and incorporate their input into trial design and logistics. This not only builds trust but increases buy-in, reducing friction later. For example,…   Read more»

One of the most impactful strategies I’ve seen for boosting employee engagement, particularly in healthcare and medtech settings, is connecting employees directly to the patient impact of their work. Hosting patient story town halls, where patients or clinicians share how…   Read more»

In addition to cost and quality, one critical factor in vendor selection is regulatory compliance. Vendors must follow standards such as ISO 13485 and be prepared for audits or inspections, especially if they’re supplying components that directly affect patient safety….   Read more»