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»

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, project managers should notify their leadership of…   Read more»

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 knowledge and capabilities. Examples of organizations…   Read more»

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 in shortening how long it…   Read more»

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 the resources for dedicated quality teams or…   Read more»

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 crash or fast track an activity. In general, when crashing…   Read more»

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 managers should focus on providing development opportunities for team…   Read more»

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 include: familiarity with the company’s processes, culture, and expectations—leading to…   Read more»

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 stakeholder pressure, speeding or skipping over the verification testing puts…   Read more»

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 are major milestones being delayed…   Read more»

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 management systems) are all reliant upon how well the project manager…   Read more»

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 regulatory requirements and the safety of patients. The requirements of the FDA…   Read more»

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 instead of continuing normally. Continuing to validate…   Read more»

Although each phase is critical, the most important phase in the project process for longitudinal success is the planning phase, as it is when the project proposal, scope, and requirements are established. Such items are crucial as they set the…   Read more»

The first step to effectively balancing expectations from all involved bodies (e.g., FDA, shareholders, and consumers) is for the PM to recognize that all these groups value different outcomes. Regulatory organizations are focused on safety/compliance, shareholders focus on ROIs, and…   Read more»

The phrase “everything is about risk” in risk management refers to the habit of organizations to contextualize decisions, meetings, and discussions around identifying/evaluating potential risk. Such a mindset is critical in the medical device industry, however, it can be excessive…   Read more»

@mmd55 You definitely bring up an interesting point about the relative importance of resources vs. management oversight in a project’s early stages. While having funding or other resources is definitely and obviously required to initiate many projects, effective management makes…   Read more»

A way companies can reduce the cost of returning to earlier development phases is through strengthening early-stage planning and risk identification. This can be facilitated by thorough design reviews, failure mode and effects analysis (FMEA), and early prototyping. As teams…   Read more»