Search results
Results from the WOW.Com Content Network
At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured have been accounted for and that all data management activities are complete. At this stage, the data are declared final (terminology varies, but common descriptions are "Database Lock", “Data Lock” and "Database Freeze"), and ...
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
Medidata Solutions is an American technology company that develops and markets software as a service (SaaS) for clinical trials.These include protocol development, clinical site collaboration and management; randomization and trial supply management; capturing patient data through web forms, mobile health (mHealth) devices, laboratory reports, and imaging systems; quality monitor management ...
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
A Site Management Organization (SMO) is an organization that provides clinical trial-related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site.
Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA.Cytel provides clinical trial design and implementation services, and statistical software products primarily for the biotech and pharmaceutical development markets.
October 2004: Parexel acquires Integrated Marketing Concepts (IMC), a privately held company based in Whitehall, PA, provider of professional marketing and communication services specialized in clinical trial patient recruitment and retention, sales lead management, teleservices, call center services, fulfillment, focus group and database ...
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research.The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.