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 o...

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 cl...

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 inve...

In my opinion, when an uncomplicated project transforms into one that requires greater resources and time than planned due to new risks even though it may not have been anticipated during the planning...

Companies will often outsource clinical trials due to both a lack of internal resources for trials and that companies that do not have the capacity to conduct these trials can bring a wealth of knowle...

I do not think the COVID vaccines are a situation where the “fast, good, cheap–pick two” rule has been broken; they are a unique set of circumstances where a significant amount of money was invested i...

I do not think quality control is intentionally avoided in small projects, but rather it is scaled differently based on available resources and the level of risk involved. Small projects do not have t...

Initially, Project Managers should evaluate both the critical path and whether the time reductions in the overall project schedule will be impacted by the reductions before determining if they will cr...

My view is that creating effective teams can be accomplished without spending a fortune; there are many low-cost options available that can make an impact if done correctly and meaningfully. Project m...

Selection of whether to hire within or externally for a project manager may rely on each individual project’s uniqueness; however, there can be many advantages to hiring internally. These advantages i...

In my opinion, giving a product its license before verifying it is unethical because it will directly impact the safety of patients in biomedical manufacturing. Regardless of any marketing or stakehol...

I have found when project delays are due to events outside of a team’s control, reassessing the project plan is the most effective way to determine the actual critical path of the project. When there ...

General management and communication skills are vital for effective execution of plans because the methods used to complete the plan (such as work permission systems, status meetings and project manag...

It is essential for a project manager to manage expectations among the investors (shareholders), the FDA, and the customers (patients), and this requires that they prioritize compliance with regulator...

In the event that a defect spike occurs during the validation phase, I think that the first thing that should be done is to formally document the defect either through deviation or non-conformance ins...