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 research scientists would cost tons of money, instead of…   Read more»

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-adjusted cost isn’t about extra or…   Read more»

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 for error due to the stringent deadline. Engage with Business Stakeholders: Conduct…   Read more»

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: The employee may be overburdened or not completely trained….   Read more»

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 technical considerations before moving ahead with the research. We…   Read more»

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 awareness of the research and how the clinical…   Read more»

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 identifying, analysing, controlling, and preventing failures that can…   Read more»

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 project manager can choose appropriately. Most of these tools are not…   Read more»

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 available. The goal is to help the project team manage with…   Read more»

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”) the distribution of risky outcomes rather than passing on the…   Read more»

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 taken seriously. Implementing robust design controls and risk management practices,…   Read more»

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 learn and improve throughout the project’s lifecycle. A defining feature of adaptive project management is its…   Read more»

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 modifications, reasons, and urgency. Conduct an impact analysis…   Read more»

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, and define scope for Creativity: Establishing a clear goal helps to understand the problem at…   Read more»

A great way to capture lessons learned is by surveying the people working on and observing the project. One benefit of a mid project survey is that you can identify and correct issues before they become a real problem A…   Read more»

There are many effective strategies present in fostering team development during execution. Establishing team culture can help in team development. Team culture is a set of shared attitudes, values, goals, and practices that characterizes an institution or organization. Company culture…   Read more»

The right balance must be found between early engagement, management of expectations, and stakeholder fatigue. The engagement path should be proportional to stakeholders’ understanding of the project, the project’s impact, and the phase of development. Most of the stakeholder engagement…   Read more»

Apart from quality assurance we need quality Control (QC) in medical device development. It focuses on identifying defects in the final products or during production to ensure that only high-quality products are released to the market. These processes involve inspecting…   Read more»

In my opinion both Bone Fix and Facto set should have a formal joint steering committee. This committee can help take major decisions and also monitor the work progress closely. The committee can take decisions on any failures or change…   Read more»