Case Study
Bioclinica Submits Periodic Adverse Drug Experience Reports (PADERs) for a Multinational Specialty Pharmaceutical Company
Bioclinica Submits Periodic Adverse Drug Experience Reports (PADERs) for a Multinational Specialty Pharmaceutical Company
Bioclinica Submits Periodic Adverse Drug Experience Reports (PADERs) for a Multinational Specialty Pharmaceutical Company Introduction Aggregate reporting is a vital tool to monitor the benefit/risk balance throughout a medicinal product’s lifecycle. The timeline, frequency and exact type of aggregate report required for submission vary amongst the drug regulatory agencies worldwide. In addition to the submission of individual case safety rep