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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. 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:

  4. 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 ...

  5. 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.

  6. Certified IRB Professional - Wikipedia

    en.wikipedia.org/wiki/Certified_IRB_Professional

    Created in 1999, the CIP program is a result of many years of discussions and planning by organizational members and leaders. It is endorsed by federal regulatory officials, professional associations, many national advisory bodies and IRB professionals who are committed to improving the quality of human research protection programs.

  7. Medical writing - Wikipedia

    en.wikipedia.org/wiki/Medical_writing

    Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.

  8. Clinical research - Wikipedia

    en.wikipedia.org/wiki/Clinical_research

    Clinical research is a branch of medical research that involves people and aims to ... it will be approved by the national regulatory authority for use in the general ...

  9. 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 ...

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