Therapeutic Areas

Dermatology

Center Overview

FXM Research is a privately owned and operated Clinical Research Site that conducts phase II, III, and IV clinical research trials specializing in Dermatology and Aesthetics/Cosmetics. Throughout the years, our ability to deliver aggressive, time bound enrollment goals, while providing trustworthy data to Pharmaceutical companies and CROs, has earned FXM Research a great deal of notoriety and fame within the Dermatology research industry.

Today, FXM Research’s success is widely regarded throughout our four operating branches: FXM Research Corp., based in Miami, Florida and home of our headquarters, FXM Research Miramar, located in the city of Miramar, Florida and FXM Research International, including two branches in Belize City, Central America.

At the core of our business and operating systems, FXM Research mission is to support pharmaceutical companies and CROs with introducing new and approved FDA medications successfully into the marketplace. We perform this efficiently and effectively by providing the highest quality service in a timely fashion and at the lowest possible cost.

• Our primary concerns are subject safety and adherence to the protocol.
• Turnover time for Regulatory Documents, budgets, and contracts is usually 24 to 48 hours.
• We offer experienced, trained, and bilingual personnel (English and Spanish), who interact with our subjects, sponsors, and CROs as a cohesive team.
• Our Principal Investigators are Board Certified Dermatologists and Certified Clinical Research Investigators with many years of extensive experience. They are located on-site and are available full-time.
• Our Principal Investigators evaluate each and every study subject.
• Most subjects are recruited through advertising and from the office of our Phi’s private practice, and/or FXM Research's extensive clinical database. We draw heavily from a Spanish speaking population, a group often under-represented in clinical trials.
• We also have continuing extensive experience with a pediatric population.
• We do whatever is necessary to accommodate our subjects' school and/or work schedule, which maximizes compliance and retention.

Clinical Research Experience

Since the year 2000, FXM Research group of companies have been involved with more than 38 of the most respected pharmaceutical companies and organizations in the world known as sponsors; conducting over 170 Clinical Trials in Dermatology.

We have acted as a clinical research site in numerous dermatological studies where our normal enrollment consists of well over 40 subjects with almost 99% compliance from such subjects.

The following are the main therapeutic conditions in dermatology that FXM Research has conducted studies of:

Facility Description

Our principal investigator, Hector Wiltz, M.D., C.P.I., is on site full time. This is because our
office houses both; our research site and Dr. Wiltz’ private practice.

Our site includes a designated research area with private examining rooms to provide confidentiality and comfort for our subjects. Furthermore, our facility also includes a secured area for studied medications, case report forms and record storage. A private office is also available to ensure comfortable, peaceful and undistracted monitoring visits for our CRA’s.

Our clinical research center is located inside the Kendall Medical Center, which is on the corner of Bird Road (SW 40th Street) and 117th Avenue with the Florida Turnpike running parallel to the center. The Florida Turnpike South can be accessed from either I-95, I- 595, I -75 or the 836 West. The center can also be accessed from the Palmetto Expressway (826 North or South) by exiting on Bird Road and heading West just past 117th avenue.

Investigator Experience

Hector Wiltz, M.D., C.P.I.
Principal Investigator / FXM Research Miami

Dr. Hector Wiltz, M.D., C.P.I. is a Board Certified Dermatologist with over 28 years of extensive experience in the field of Dermatology.

As of late, Dr. Wiltz has conducted over 115 Clinical Research trials serving as the Principal Investigator for FXM Research Corp in Miami; FL. Dr. Wiltz has attended a GCP seminar, sponsored by ACRP, and completed Investigator Training for Medical Research, sponsored by WIRB, in May 2004.

He is certified as a C.P.I. and is an active member of Alpha Omega Alpha National Honor Medical Society, the American Academy of Dermatology and the Florida Medical Association.

Staff Expertise

Hector Wiltz, M.D., C.P.I.
Principal Investigator
Dr. Wiltz is a board certified Dermatologist with over 28 years of extensive experience. Furthermore, Dr. Wiltz has acted as Principal Investigator on over 115 successful Clinical Research trials.

Francisco Moncada, R.N., B.S.N., C.C.R.C.
President & Director of Clinical Research
Mr. Moncada is the President and Director of Clinical Research for the four separate branches that structure FXM Research. Francisco Moncada has worked with Dr. Wiltz for over 22 years and has extensive experience in most dermatological conditions and disorders. In the year 2000, Mr. Moncada founded his first clinical research site FXM Research Corp. with operations in Miami, FL. Today, the site in Miami has conducted over 115 Clinical trials in dermatology under the Direction/Management of Mr. Moncada.

In late 2006, after many years of achieving outstanding results conducting clinical trials, Mr. Moncada widened his prospective to the international arena by founding FXM Research International which today, consists of two solid and experienced research sites in dermatology located in Belize City, Central America. Together, these sites have successfully conducted over 28 studies.

To further widen the scope of opportunities FXM Research has to offer to Pharmaceuticals and CRO Sponsors in the United States, the latest branch of FXM Research, FXM Research Miramar, with operations in the city of Miramar, FL; was founded in late 2008. Today, the youngest of the four sites is proud to have conducted over 27 studies in Dermatology. As Director, Mr. Moncada’ job is to handle all Regulatory aspects involved in the trials, oversee the success and achievement of all personnel assisting in the trials, and supervise subject’s conduct during the trial. Mr. Moncada’ management directive is to ensure all of the FXM Research sites convey the same unequivocal quality of standards each has to offer. Mr. Moncada has attended a GCP seminar, sponsored by ACRP, and completed Investigator Training for Medical research, sponsored by WIRB, along with Dr. Wiltz in May 2004. He is certified in HIV/OSHA/BBP-TB, CPR, ACLS, PALS, AND IATA regulations.

Antonio Jimenez, B.S. Chief Operating Officer

Maritza Blandon, Chief Finance Officer

Edmar Jimenez, Administrative Service Analyst

Lourdes Serrano, Senior Lead CCRC.

Maria Ambros, RMA, CRC.

Maritza D. Blandon, B.S., Lead CRC/Assistant Director

Yaneysi Alonso, CMA Clinical Research Coordinator

Alejandra Mangual, B.A. Clinical Research Coordinator

Ana B. Retana, Clinical Research Coordinator

Mario Vasquez, B.S., Clinical Research Coordinator

Yasmelly Poggio, Executive Secretary

Rosalina F. Ortiz, B.S., Executive Secretary

Patient Demographics

We are always ranked among the highest enrolling sites in trials we participate in. This is
because of our extensive patient/subject database. Our patient/subject database consists of all patients treated in Dr. Wiltz’ private practice, as well as, FXM’s own subject database.

Our patient/subject target population consists of the following and includes males and females of all age groups:

57% Hispanic
21% Caucasian
19% African American
1% Asian
2% Other

Our subjects give us several reasons why they decide to participate in our Clinical Research studies. The ones they most often mention are:

• To help in the development of new medications that may offer better treatment or even
  cures for chronic diseases.
• The availability of diagnostic tests and medical evaluation of a particular disease or medical condition without worrying about the cost.
• The Hope for a new approach or treatment that finally offers some relief. For all subjects' database management, we comply with privacy and confidentiality of all HIPAA regulations.

Other Information

For all regulatory issues we adhere to the assigned Central Institutional Review Board.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.