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 […]
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. […]
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 […]
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 […]
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, […]
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 […]
Safety precautions take during clinical trials are certainly the most important aspect. There are two groups which have scientific oversight: the sponsor and the physical investigator (doctor). Additionally, the FDA reviews them along with independent review boards. There is also “Informed Consent”. A patient consents to all the trial rules before the trial begins. Thus, […]
There are many reasons why a clinical trial can be delayed. The main reason for delay is bad planning. Other reasons include: recruitment, data cleaning and proper documentation. “Lack of Efficacy” is an important aspect of clinical trials. Efficacy is the effectiveness of the drug in curing the disease. However there are many drugs which are […]
Twenty tree years after the NIH created the Revitalization Act to increase the number of women and minorities in clinical trials, they still seem under-represented in drug trials. Is that still the case? There were some well-known drug trials where minorities were mistreated. Women were not even allowed to participate in trials for a long […]
Complex project management for clinical trials is a very critical part of the clinical drug trials planning. Most clinical trials typically run 45% over budget. There are several reasons for this occuring: 1. Lack of discipline in being able to manage a complex project. 2. Lack of understanding of your resources. 3. Financial data: Unable […]