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Research

Allameh Medical Corp (AMC) is active in reasearch studies

Clinical Research is determined to facilitate the development of new medication that can improve patients’ health with various medical conditions.

We strive to be on the forefront of clinical research by producing high-quality data and excellent patient care. Our mission is to improve patients’ health through research.

Our staff is provided with training in GCP, ICH and FDA guidelines. New staff members are required to attend outside clinical training programs.

Our site incorporates Standard Operating Procedures (SOPs) that allow our site to perform efficiently and effectively resulting in reduced monitoring times and data queries.

Our site is equipped to handle phase II-IV trials and have specialized medical equipment including -20 degree freezers and refrigerated centrifuges.

We are detail oriented and willing to listen to our patients.

Independent research company. We operate out of private practice in Mission Viejo, CA. Our location enables us to have access to a large, ethnically diverse subject population in a family oriented setting in Orange county.

We have a well-qualified team of professionals devoted to excellence in all aspects of research.

Facility description

  1. 3 exam rooms
  2. Research office for Clinical Research Coordinator
  3. Dedicated lab with Blood drawing area and centrifuge
  4. Locked cabinet for regulatory and source documents
  5. Locked and temperature-controlled drug storage cabinet, monitored , daily temperature logs
  6. Medical refrigerator with traceable thermometer
  7. -20°C freezer with traceable thermometer
  8. A large array of other medical equipment.
Clinical trial (Clinical Research):

A scientific study that tests the safety and the effectiveness of a new medical treatment, drug, or device with patients.

Clinical investigator:

A medical researcher in charge of carrying out a clinical trial's protocol. Allameh Medical Corp physicians are clinical investigators.

Food and Drug Administration (FDA):

The government agency that sets guidelines on the manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.

Informed consent:

The complete and open discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential patients. The FDA requires all patients to sign an informed consent form before participating in a trial.

Independent Review Board (Institutional Review Board):

A group of health care professionals from the institution where the clinical trial takes place, as well as members of the local community. The Board is responsible for seeing that there is not unreasonable risk to the patient and that the informed consent accurately informs the patient about his/her role in the study.

Investigational treatment:

The drug or device being tested during a clinical trial.

Pharmaceutical/biotechnology company:

A business that researches, develops, tests, manufactures, and/or sells medical drugs and devices.

Protocol:

A detailed plan carefully designed by a clinical trial sponsor. It sets guidelines for a trial and usually involves several different trial locations.

Sponsor:

The pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs its protocol.

Standard treatment:

A treatment currently in wide use and approved by the FDA for a particular disease or illness.

In some trials involving new investigational treatments, there may be no pre-existing treatment at all. In these cases, the lack of any treatment is itself considered the standard treatment.

Generally, the investigational treatment is hoped to be safer or more effective than the standard treatment.

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