Tag Archives: clinical trial management

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. […]

Why Do Clinical Trials Take So Long to Start?

Clinical Trials take too long to start. The clinical trial managers may not start a trial from 6-9 months to even 12 months. This is more time than it should. Research has shown that many prescription drug companies accept inefficiency. The threshold is much too high for inefficiency. Many clinical trial tools are antiquated, such […]

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 […]

Managing a Clinical Trial

Clinical Trials are mammoth projects. They may be staffed by 200 people or more. Doctors, nurses, technicians, administrators, interns and others are involved. Anyone of them can make a mistake duing the trial which can cause huge problems or ven delay the completion of the project. They are, however, controlled by the parameters of the […]