Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches th
The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a tr
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval