Tag Archives: clinical trial

The Clinical Trial Startup

A typical Clinical Trial Startup is usually delayed because of poor planning. The project manager has to hire a strong, professional clinical trial team. Then, processes such as SOPs and trial templates take time. If they fail to get these done, the clinical trial is delayed. The clinical trial project manager can have those systems […]

FDA Regulation of Software in Clinical Trials

Not all software is regulated by FDA. Some software may be regulated depending on what it does. You can take a lot of what we know about clinical trials and design them for the task. FDA does not regulate the software. They take a hands-off approach. They let companies design systems to work for them. […]

What is a Clinical Trial Feasibility Study?

Clinical Trial Feasibility Studies means finding the right investigators and patients then determining costs. It is done to evealuate how the test could fail then decide to proceed or not to proceed. The project manager and trial sponsor take the lead. They look at the records of investigators and see if they are able to […]

Managing a Clinical Trial Project

A clinical trial project manager keeps track by using checklists, forms and other tools. They distribute tasks to each member of the team which is part of the SOP in a clinical trial. Updating emails and catching up with team members can be time-taking. Project Managers spend more than half their time tracking tasks, deliverables […]

Why Do Clinical Trials Take So Long?

A smaller clinical drug trial could take about a year while a larger clinical trial could take many years. It depends on how the trial is executed. While there are factors that you can’t control it typically takes a year from start to finish. A smaller clinical drug trial could take about a year and a larger […]