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2. Clinical trial management system - Wikipedia

   en.wikipedia.org/wiki/Clinical_trial_management...

   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.

3. Clinical data management - Wikipedia

   en.wikipedia.org/wiki/Clinical_data_management

   The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the data manager ensures that data are collected, validated, complete, and consistent.

4. Clinical trial - Wikipedia

   en.wikipedia.org/wiki/Clinical_trial

   A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...

5. Clinical data management system - Wikipedia

   en.wikipedia.org/wiki/Clinical_data_management...

   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.

6. Clinical research associate - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_associate

   The CRA may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a contract research organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol , checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with ...

7. Site management organization - Wikipedia

   en.wikipedia.org/wiki/Site_management_organization

   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.

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9. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...