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Frequently Asked Questions
A: A clinical trial is a research study to test new treatments. The test article(s) is evaluated to determine if it is better than or the same as existing treatments. Clinical trials are the fastest and safest way to find future treatments for disease. Q: What is a protocol? A: A protocol is a document that describes the rationale, objectives, and procedure of a clinical trial. Each protocol is carefully designed to safeguard the health of the participants, as well as answer specific research questions. A protocol describes what types of patients may participate in the trial, the schedule of tests, procedures, medications, dosages, and the length of the study.
A: Pharmatech is your resource for easy access to the latest clinical trials on the market today. Our experience and expertise in research management will help you to integrate research into your daily operations. Pharmatech’s research staff will provide training, study initiation support and enrollment guidelines to help you achieve success.
A: The sponsor can be the pharmaceutical company, research institution, or another health organization that funds a clinical trial and/or designs the protocol.
A: A Contract Research Organization (CRO) is a company contracted by a pharmaceutical or biotechnological manufacturer to manage clinical trials. CROs perform services such as, data management, statistical analysis, protocol design, and final report development. A Site Management Organization (SMO) performs and manages research for individual Investigative Sites. SMOs' responsibilities include patient recruitment and protocol management. A: A Research Management Organization (RMO) functions as a combination of a CRO and SMO to manage research from the conception and development of a project to the implementation and completion at Investigative Sites. Q: Is Pharmatech an RMO, CRO or a SMO? A: Pharmatech is a Research Management Organization (RMO). With a site-centric approach, Pharmatech manages research from the conception to the development of a project while offering a variety of services to each Investigative Site. There are no costs for these services to the Investigator, which distinguishes Pharmatech from a traditional SMO. These services include: project management, regulatory submission and management, data management, grant management, as well as training and certification programs.
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