As mentioned previously, there are different stages to recalls; each one being more severe than the other. The FDA can inform the company on a strateg...

The cheap aspect of fast-good-cheap is one topic that may be up for discussion. More specifically, much of the financial aspects of developing a vacci...

Certain jurisdictions allow for streamlined product approval by using clinical data obtained from other jurisdictions. This is called a data-reliance ...

Assuming that once a smaller companies has identified a suitable clinical trial management company to contract with, payment could become a key part i...

One factor which can make or break communication within a clinical trial and project is communication latency. The time from delivery to acknowledgeme...

One reason that a company may want to outsource their clinical trials is for scalability reasons. With small companies, a limiting factor for clinical...

Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likel...

WBS should be closely aligned with a company's risk management planning. Different deliverables like the change history are effective in a WBS, but in...

Adding on to what was said, an effective way to manage time compression while mitigating risk if employing a scenario-based method that can evaluate t...

As you mentioned, EVM is a good tool for identifying if a project is behind schedule by using EV and PV. One additional benefit of EVM is its ability ...

Capturing lessons learned by using a slideshow presentation or using software like sharepoint is a good idea, but making these efforts to capture the ...

The main key aspects of the preparation for a design review were covered previously, however one critical step for preparation is engaging with stakeh...

For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an ...

One way to prepare for challenges in the product development process early is to organize review meetings with team leaders from cross-functional team...

Making sure that relevant metrics are collected efficiently and correctly are indeed an important step in the project process. One way to make sure th...