Everyone has brought up great points about how emergency authorizations and tightened timelines impacted the project management phases during the pandemic. I’d like to add that one significant shift i...

I really like how everyone emphasized due diligence and matching the CRO to the specific needs of the trial. Building on these ideas, I think relationship management should also be a major considerati...

I really like the points raised so far about digitization and its potential in clinical trial management. Expanding on that, eClinical platforms (such as electronic data capture (EDC) systems, electro...

Building on the excellent points already raised, one additional strategy is to engage stakeholders early in protocol development and incorporate their input into trial design and logistics. This not o...

One of the most impactful strategies I’ve seen for boosting employee engagement, particularly in healthcare and medtech settings, is connecting employees directly to the patient impact of their work. ...

In addition to cost and quality, one critical factor in vendor selection is regulatory compliance. Vendors must follow standards such as ISO 13485 and be prepared for audits or inspections, especially...

Project management software plays a crucial role in automating, organizing, and optimizing project planning and execution. Tools like Microsoft Project, Primavera P6, and Smartsheet help manage tasks,...

The ethics of using procurement to pressure suppliers into adopting environmental or social policies depends on intent, transparency, and feasibility. On one hand, companies have a responsibility to e...

Effective project management requires balancing scope, time, and cost while remaining flexible to unforeseen challenges. Another of the biggest threats to project success is scope creep, where uncontr...

Going back to a previous phase in project development is often costly and time-consuming, but in some cases, it is necessary to ensure compliance, functionality, and safety (especially in highly regul...

Early start (ES) and late finish (LF) dates in project scheduling are determined by multiple factors, including task dependencies, resource availability, and project constraints. The early start date ...

Transference as a risk management strategy is widely used in the pharmaceutical and medical device industries, particularly through Contract Manufacturing Organizations (CMOs) and Contract Research Or...

Project plan execution is where careful planning meets real-world challenges, and success hinges on proactive problem-solving and strong team coordination. One key factor in execution is risk mitigati...

Project Integration Management (PIM) ensures that all aspects of a project work in harmony by coordinating multiple process groups. While the Project Charter and Project Management Plan (PMP) establis...

The FDA manages the issue of companies selectively choosing favorable toxicity test results through strict regulations, mandatory transparency, and independent audits. All toxicity data, both positive...