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2. Clinical research associate - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_associate

   A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.

3. Independent safety officer - Wikipedia

   en.wikipedia.org/wiki/Independent_Safety_Officer

   The timing of the meetings depends on the risk to the participants as well as the degree of oversight needed for a particular trial. [7] If a clinical trial has regulatory lapses, excessive adverse events linked to the trial intervention, or fails to recruit adequate numbers of participants, the ISO may recommend that the clinical trial ...

4. List of Guidances for Statistics in Regulatory Affairs

   en.wikipedia.org/wiki/List_of_Guidances_for...

   CPMP/EWP/1776/99: Missing data in confirmatory clinical trials [21] (EMA) explains how the presence of missing data in confirmatory clinical trials should be addressed and reported in a dossier submitted for regulatory review. It provides an insight into the regulatory standards that will be used to assess confirmatory clinical trials with ...

5. Regulatory affairs - Wikipedia

   en.wikipedia.org/wiki/Regulatory_affairs

   Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...

6. Pharmaceutical physician - Wikipedia

   en.wikipedia.org/wiki/Pharmaceutical_physician

   In addition to regulatory guidance, pharmaceutical physicians often lead clinical development teams, shaping the medical strategy for drug development. They may occupy various senior roles within companies, such as Chief Medical Officer (CMO), Medical Director, Clinical Development Physician, or Clinical Research Physician.

7. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today ...

8. Contract research organization - Wikipedia

   en.wikipedia.org/wiki/Contract_research_organization

   The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...

9. Clinical research coordinator - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_coordinator

   A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [ 2 ] as: