Time: May 17, 2018 at 9am to May 18, 2018 at 6pm
Location: Philadelphia, PA
Street: Philadelphia, PA
City/Town: Philadelphia, PA
Website or Map: https://www.globalcompliancep…
Event Type: seminar
Organized By: John Robinson
Latest Activity: Mar 22, 2018
When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. 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 to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.
This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring.