One way to look at the decision is through the balance between control and consistency. A company running a clinical trial in-house keeps direct oversight of how the study is executed, how data is handled, and how quickly adjustments can…   Read more»

One point worth taking seriously from this discussion is that project management thinking is not something that only applies to whoever holds the official title. People in purely technical roles carry that perspective into their work too, and it changes…   Read more»

A project manager works with sponsors by serving as the link between what the sponsor is asking for and what the team can realistically put out. That means picking up broad goals and converting them into actual tasks, timelines, and…   Read more»

I can relate to this because I also tended to have tunnel vision during the simulations. What helped me the most was working with my team. They would bring up different ideas or challenge my thinking, which forced me to…   Read more»

I agree that job satisfaction is important. At the end of the day, people leave for better opportunities. Most individuals are always looking for growth, whether that means higher pay or a promotion. Even if someone likes their job, it…   Read more»

I agree with your point that a lot of people work extra hours because of peer pressure and expectations, not just motivation. In my experience, it is pretty common to feel like you have to stay busy or be available…   Read more»

So my personal views on substantial data are probably not the ideal course of action for medical devices. Medical devices are special and lifesaving so it is important to be rigorous with the idea of substantial. The definition of substantial…   Read more»

For the simulations, when I am working on it on a timely manner, I love to ask questions at the very beginning to have a better understanding as to what exactly is happening. This allows me to home in on…   Read more»

I believe that Americans put in a lot of work compared to people of other countries for a few reasons. First, I’ll talk about my experiences visiting the countries of my parents in central and south america. In these locations,…   Read more»

There are several good points listed in the responses here. To play the devil’s advocate, I’d like to point out potential pitfalls to overly relying on this digitization approach. First and foremost, having patient data easily accessible digital will always…   Read more»

Reading through the replies, there are several very good points and insight offered for how a smaller/less experienced company would handle this kind of situation. One suggestion I didn’t see mentioned but is crucial is this: hiring the right people….   Read more»

@kaf43 agreed! Reading other points and yours, there are several good points brought up which include lessons learned. While going through a lessons learned is important and understanding how and the why the failure occurred; I want to emphasize the…   Read more»

Failure is obviously a great opportunity to grow, it can be a signal to equipment that may not be working, systems that are lagging, and can spotlight alternatives that can be best implemented in future projects. A team can fail…   Read more»

Job satisfaction in the way I’m interpreting it seems pretty broad, I will assume you mean something along the lines of, “are you happy with the role/work you are in?” I believe less it is the entry thought of whether…   Read more»

The project manager is the main driver of the project and is the guide for the team. Naturally they hold a lot of influence in the team’s motivation and attitude towards the project. A motivated project manager that holds passion…   Read more»

For smaller companies without their own clinical trial management departments, it is important to ensure that they have the proper structure in place to maintain oversight of the CROs and their work on behalf of the sponsor or smaller company….   Read more»

Clinical trials in the 21st century should be far more digitized and data-driven than many are today. Today’s clinical trials are generally based on paper-based systems, which provide delays in the clinical trial process, provide opportunities for transcription error, and…   Read more»

If a recall request is made by the FDA or any other Regulatory Agency, I believe that the company’s initial response should consist of rapid containment, transparent communication, and root cause investigation. The first priority must always be to protect…   Read more»

I agree with your point, especially about how the outsourcing is not just about smaller companies lacking resources, but also about access to expertise and efficiency. Even if a company has the ability to run trials in house, I think…   Read more»

It can often be more effective for a company to prioritize the prevention of demotivating within a current workforce while still valuing a self motivated hire. Usually hiring self motivated individuals is important, but these highly driven employees can become…   Read more»