Frequently Asked Questions

What is a clinical program?
Is clinical research safe?
Is the program monitored?
What are the benefits?



What is a clinical program?
Clinical research programs are funded by pharmaceutical companies specifically for evaluating the effectiveness and safety of medication on patients.


Is clinical research safe?
Before the start of a clinical study strict protocols and procedures are developed. These guidelines are reviewed by an Institutional Review Board to ensure compliance with Federal regulations. This review process ensures that patients are protected and that the program does not present undue or unnecessary risks.

Is the program monitored?
Yes. All patients are monitored throughout the
program by experienced and skilled research coordinators and physicians. This monitoring process ensures that program procedures are followed for maximum patient safety.


What are the benefits?
Patients enrolled in a clinical research program gain access to research medications.

Tomorrow's Treatment Today. Volunteer patients are always needed to enhance the quality of life for all people suffering from psychiatric and neurological disorders.

All investigational drug research protocols are reviewed and approved by an Institutional Review Board (IRB) in compliance with federal
regulations.

FDA requires an IRB to review all the research documents (e.g., the protocol, the consent form, and the investigators brochure.), and activities that bear directly on the rights and welfare of the subjects of proposed research. Sponsor personnel visit the investigative site regularly to ensure that the investigative staff are in compliance with regulatory requirements and company policies. They also monitor data collection and ensure accurate documentation.

Primary investigator and the designated sub-investigators shall conduct the study in accordance with all applicable federal, state, and local laws, regulations and guidelines, including but not limited to the Federal Food, Drug, and Cosmetic Act as amended, and regulations promulgated thereunder (the "Act") and the U. S. Food and Drug administration ("FDA") regulations governing the protection of human subjects.


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