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 do them again for FDA approval.
There are several solutions, available, however. Most are customized solutions developed by company project managers. Microsoft products such as Microsoft Excel still are commonly used by most project managers. They create a worksheet and then follow it. Many ophisticated project managers may also use Microsoft Project with the tools that navigate a project.
Customized project management tools have also been developed to make it easy to manage a clinical trial project. While there are many solutions out there, there is no standardized solution or one solution for that everybody uses. Nor, is there one solution more popular than another. (Though there are differences based on preferences. Even the same clinical trials would take slightly different tools.)
Ironically, clinical trials are a valid, necessary project. More than fifty years of history of doing clinical trials has occured. And, ninety percent of the clinical trial work is identical to another trial. So, there are a lot of common processes or common themes.
One of the challenges is not being able to maximize on those similarities but instead they focus on the differences. Most common tasks are automated so there is less wasted time and expense. Project managers spend about half their time chasing projects either updating thigs, answering emails and other usual tasks.
DLTA realizes that drug lifecycle data is an automation tool. It takes the similarity of the processes and puts them in the software so people don’t have to remember. The software does the mundane tasks automatically.
DLTA, Drug Lifecycle Tracking Application maps the end-to-end drug approval process. It offers a one stop shop to manage Drug Lifecycle and Regulatory Review process. The application includes built-in tasks, durations, dependencies, key milestones and forms to capture relevant meta-data for each step. And DLTA also provides reports to show complete visibility of all drug approval tasks, their priorities and progress. For more information call us at (240) 753-8282.