How to Set up a Clinical Research Center in Your Medical Office

Are you losing money due to late medical claims payments? Many doctors are seeking other opportunities to continue practicing medicine and make money from it, after all, they went to medical school because it was what they wanted to do as a career – not a job. One obvious opportunity is to become a Principal or Clinical Investigator for pharmaceutical and bio-technical companies with promising new therapies to treat diseases and conditions that plague humans. Here are a few tips on starting your clinical research center and continuing with your career of choice.

Difficulty: Challenging

Instructions

Things You'll Need:

• Basic knowledge of Good Clinical Practices

1. Assess your office.
   
   Step back and look at your office and determine the amount of space you have available. Is there space for investigational drug and device products to be stored securely such as a locked cabinet? Is the cabinet metal or wood and does it hold heat? If it holds heat or is situated near a window where the sun rays can generate heat, you will need to move it or find another location for storing your investigational drugs and devices.

2. Do you have qualified staff?
   
   Try to find at least one doctor or dentist (depending on the center you’re setting up), who can fill in for you if you are unavailable, such as on vacation. Hire a Clinical Research Coordinator with healthcare training, preferably a nurse, physician assistant or EMT. Ensure the staff learns Good Clinical Practice regulations and international guidelines.

3. Assess your equipment.
   
   Is your equipment controlled, calibrated and qualified? Do you have documentation showing the equipment is properly maintained and functioning correctly?

4. Learn HIPAA and Good Clinical Practice (GCP) regulations.
   
   The most important things to know and follow to be a successful Clinical Investigator are Human Research Protection, Health Insurance Portability Accountability Act (HIPAA), and the information on the back of the FDA Form-1572 governing your commitment as a researcher. General GCP knowledge is a must and training should be ongoing, documented and maintained in case of a FDA or sponsor inspection.

5. Find Patients.
   
   Make sure you have a patient population to review for clinical trial eligibility. Sponsors will want doctors capable of providing human subjects for their clinical trials. Usually, a patient can not be enrolled in two clinical trials at one time and most require at least a 28-day washout period between trials, so it is imperative for success that you have access to hundreds of patients who are willing to volunteer for a clinical trial.

Resources

• Learn More About Good Clinical Practices
• Food and Drug Administration
• Office of Human Research Protection

[MIghtyDreamer]

on 5/15/2009 sounds like reasonable and sensible tips for setting up a medical research center in one's medical office

[sonni57]

on 5/12/2009 Thanks for the helpful article on how to set up a medical research clinic.