What are Clinical Trials?

Before a drug goes to market there has to be exhaustive testing to see if the drug works and if there are any side effects. These are strictly controlled conditions.

Clinical Trials is the official term for this type of testing. In the beginning Phase 1 trials is a very small trial and done in a few locations and clinics. Then, it moves to Phase 2 and Phase 3 which are larger trials. These phases involve many more patients and clinics.

Besides the size of the trial, from an operational point of view the trials are identical. The kinds of approval needed by the FDA are similar as are the exact steps you take are similar. A large trial is done mainly to replicate or mimic the commercial market. A small trial is done to see if the drug is safe.

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 (240) 753-8282.