Author Archives: Editor

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 […]

Why Do Clinical Trials Fail? (Part 2)

Project Managers often have to deal with an unproductive team. It is a challenge that the project manager has to troubleshoot. There are many possible reasons that the team does not perform well. The Project Manager needs to find the root cause and fix it, as soon as possible or the clinical trial is in […]

Why Do Clinical Trials Fail? (Part 1)

Clinical trials fail. That is a fact of life as a recent study (2015, Clinical Development Success Rates for Investigational Drugs)¬†found that 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. Only half of all drugs are rejected during the process and fail due to a lack […]

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 […]

What are the New Clinical Trial Technologies?

Clinical Trial Project Managers are are not necessarily using the newest technologies in the marketplace. Microsoft Project is popular but it is twenty-years old. Inertia is the main reason for not switching to the new technologies. Most technologies require a learning curve and project managers are averse to doing it because it takes time to […]

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 […]

How Can Clinical Trial Costs Be Reduced?

Clinical Trial costs can be controlled and reduced by following protocol. Drug trials have been done the same way for the last fifty years or so. There have been very few changes in protocols. Clinical Drug Trials need a team of technicians, doctors, nurses and administrators who do the project step-by-step and stay within the […]

Who Manages Clinical Trials?

Project Management of any clinical trial is usually done by trained and experienced managers who are able to mange a group of sixty people or more across the country or the world. The FDA does not require a license or certificate for project managers. Most managers must have a strong sense of coordination, organization and, […]