Sofpromed offers clinical trial management services for phase II studies worldwide across all therapeutic areas.
A phase II trial is a study that evaluates whether a new therapy is effective and safe for a certain kind of disease.
In oncology, for example, efficacy is measured by radiological tumor response, progression free survival and overall survival.
Phase II clinical trials also generate data regarding the safety of the drug and how the treatment affects the patient.
Our phase II services include regulatory affairs, site qualification, site management, clinical monitoring, data management, trial logistics, pharmacovigilance, biostatistics, medical writing, and project management.