Companies outsource clinical trials for multiple reasons, 1) Cost reduction: The company does not have the proper infrastructure to conduct the trials independently. The cost of hiring a team of good ...

We can follow the below strategies to convince management on investing more, 1) Define risk adjusted costs: When planning for a project, we often think of cost as just the money we’ll spend. But risk-...

The Project Manager can address the situation by undertaking the following actions: Clearly Understand Requirements: Ensure a thorough understanding of the project requirements, as there is no margin...

Imagine you land upon a job opportunity which has an exciting and challenging project, something you were passionate about. But as time passes you realize a downside to it that there is no long term g...

Having additional strategies and frame of mind can be always helpful in clinical research. Low performance can be handled by doing an assessment and troubleshooting the problem. 1) Root cause analysis...

To maintain a good scientific rigor, Before we start collecting and analyzing data, you need to have a clear and specific research question and hypothesis. We should consider ethical, practical and t...

Some of the unique challenges in clinical trials areSubject recruitment: One of the biggest challenges in clinical trials is the right patients at the right time to really achieve a fast.Even simple ...

Additional risk management and precautionary measures need to be taken. I think below steps can help to prevent quality and risk failures. 1) ISO 14971 Medical device: management is a process of ident...

Various software project management tools have been used to manage and support project activities. They help in planning, monitoring, and controlling. The features these tools provide vary, and the pr...

The concept of Progressive Elaboration can simplify the work breakdown structures. Progressive Elaboration is a method of continuing to provide further details of the planning process as it becomes av...

Risk transfer is commonly confused with risk shifting. To reiterate, risk transfer is passing on (“transferring”) risk to a third party. On the other hand, risk shifting involves changing (“shifting”)...

While there's no universal metric defining the exact degree of deviation warranting a rollback, the overarching principle is that any deviation posing a risk to safety, efficacy, or compliance is take...

Adaptive project management is how projects are executed in today's environment. Unlike traditional methodologies, this approach embraces flexibility and adaptability, continually allowing teams to le...

I would take below steps if the customer requests changes to the project scope after the execution has started. Understand the change in detail and document the request formally, including specific...

An organization can follow below methodologies to strike the right balance between maintaining control and allowing flexibility for creative problem-solving and adaptation. 1.Define Clear Guidelines, ...