Sofpromed provides full clinical trial management services for early phase studies worldwide across all therapeutic areas.
Early phase trials are the first step in testing new drugs in humans.
The goal of early phase trials include finding out the adequate dose for a new drug, studying how often the drug should be given to ensure effectiveness, assessing safety (side effects and toxicities), preliminary efficacy of the compound on the disease, and how the body absorbs, circulates, and eliminates the new medication.
Sofpromed offers a wide range of services for first-in-human clinical trials ensuring that the drug will make progress into phase-2 human testing quickly.
We cooperate with phase I units located in hospitals, including emergency rooms to offer the best facilities for performing first-in-human safety trials.
Our phase I capabilities include regulatory affairs, site selection and activation, site management, onsite monitoring, data management, logistics management, drug safety, biostatistics, medical writing, and project management.