Clinical Drug Trial Site Management Key Terms

Get to know some key terms in clinical drug trial site management

Clinical trial site management is a burgeoning field of study that is comprised of investigators who are responsible for assessing the effectiveness and safety of an already established medication or device as well as a new one. Investigators will seek out and sign up healthy volunteers in studies that are usually designed to compare one product or device with another. Because humans are involved, there are very strict protocols and processes built into these types of studies. There are considerable costs for a full series of clinical trials and so sponsors are usually either biotechnology or pharmaceutical companies. There are a myriad of unique terms associated with this profession for you to become familiar with if you are interested in a career in this field.

 

Contract research organization

A contract research organization or CRO is also referred to as a clinical research organization. A CRO provides support to the pharmaceutical industry by offering a range of "outsourced" services including clinical drug site trial management which can include selection or monitoring of investigations, design of protocols and evaluation of reports on studies.
Try: For a more comprehensive definition see drugdevelopment-technology.com.

Electronic submission gateway

Electronic submission gateway (ESG) is an entity that was designed and constructed to provide a central transmission point for sending information electronically to the FDA. Clinical drug trial site managers know how to navigate ESG standards.
Try: For a definition on ESG see GlobalNet Services. For an overview of the standards and the official website that outlines the ESG go to CDER.

ICH

ICH stands for the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use and is a project that assembles regulatory authorities and experts in the pharmaceutical industries from the United States, Europe and Japan to discuss the technical aspects of pharmaceutical product registration. Clinical drug trial managers understand the importance of this agency.
Try: The official website for ICH can be found at ich.org.

EMEA

EMEA is the European medicines agency and is responsible for the evaluation of medicinal products. Similar to the FDA in the United States, the agency was established to harmonize and coordinate the work of national medicine regulatory agencies in Europe. Clinical drug trial managers know how to work with the EMEA.
Try: For more information you can go to EMEA.

Pharmacovigilance

Pharmacovigilance is a science that detects, assesses, understands and prevents the adverse effects of medicines. It is comprised of researching, monitoring, collecting and assessing information from a wide variety of sources on the undesirable effects of medications. Clinical drug trial managers know that pharmacovigilance is absolutely necessary.
Try: For more specifics on what pharmacovigilance entails you can check out RTI Health Solutions.

Data mining

Data mining is the process of taking data and analyzing it for hidden patterns so that more concise information can be extracted and used for decision making. Clinical drug trial managers mine data as part of their routine tasks.
Try: UCLA Anderson School of Management has a great overview and examples of data mining.

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