Both post market authorization surveillance programs and clinical phase IV studies are essential to ensure the safety of drugs.
These studies also reveal beneficial and detrimental effects of drugs often only detected in large populations or long term follow ups. Examples of effects best detected in post marketing programs include causal effects, risk factors, economic consequences, and characterization of drug use in clinical practice. Phase IV clinical trials encompass the detection, assessment, understanding, and prevention of drug-related problems.
TFS can support in all areas of post authorization trials like PASS, Phase IV, RWE, Registry trials etc.