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. It must meet a certain quality, however. The FDA has minimal software standards.

Software technologies take away all the mundane tasks that we do. It isn’t thinking for you but it takes away all the things you think about and then lets you focus on the trial.

DLTA takes away all of the mundane tasks, admin jobs and other tasks in a complex project. It makes it easier for you to focus on your clinical trial.

DLTA helps in the planning, administration and execution of clinical trials. 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. Call us at (240) 753-8282.