Tag Archives: FDA approval

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 […]

What delays clinical trials?

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 […]

How Would the Trump Administration Affect Clinical Trials?

The new Trump Administration will be overseeing clinical drug policy. The big question is: How will this new administration affect clinical trials? Clinical trials are rarely influenced by the politics. Most clinical trial rules are fifty years old and well-established as are international standards. . The Trump Administration has talked about cost reduction of drugs. […]

The Patent’s Role in Drug Testing

Many segments of the American population do not participate in clinical trials. These same patients also rarely give feedback on the drugs they are taking. However, that can be improved as there are several ways patients can help with developing different prescription drugs:  If you have a disease, get involved with your patient support groups.  […]

Product Lifecycle Management

There are many reasons for drug delays in the product lifecycle management process. The Number 1 reason for delay for drugs coming to the market is due to clinical trials. Clinical trials take the longest time in any drug development cycle.  They are also the ones that go wrong the most often because people have to […]