Sofpromed offers clinical research management services for late phase studies worldwide across all therapeutic areas.
Late-phase studies (phases IIIb and IV), also known as post-approval or observational studies, are conducted to evaluate a drug’s long-term effectiveness and impact on a patient’s quality of life over a longer period of time. These studies provide ongoing safety information through long-term evaluation of patients in a real-world setting.
Regulatory agencies may require additional data about the side effects of new compounds. Then, biopharmaceutical companies require additional safety information that may not be available from phase III studies.
Our late phase services include regulatory affairs, site qualification, site management, monitoring, data management, trial logistics, pharmacovigilance, biostatistics, medical writing, and project management.