5941 NW 173 Drive, Suite 1 Miami, FL 33015 PH (305) 424 - 7420 FX - - PDF document

Site Presentation Letter Responsive research

for the whole body and mind

5941 NW 173 Drive, Suite 1 ▪ Miami, FL 33015 ▪ PH (305) 424-7420 ▪ FX (305) 424-7427 www.sanmarcusresearchclinic.com

San Marcus Research Clinic, Inc. is a high quality research organization established to promote and encourage development and advancement made in research, diagnosis, treatment and cares for the whole body and mind. San Marcus Research Clinic was founded to meet the challenges

• r Responsive clinical research and to support the pharmaceutical biotechnology and medical

devise industries in their quest for expediting drug approval by the Federal Drug Administration. “San Marcus” contracts with or employ’s physicians, nurses and health care providers on both full-time and part-time basis to serve as investigators and study coordinators for clinical trials. A full time site director of clinical studies will staff “San Marcus’” clinic and several study coordinators. The clinic may also maintain a pool of part-time registered nurses or assistants who are retained and assigned to specific studies as volume demands. “San Marcus” will also contract with other physicians to serve as investigators on clinical trials, which require medical specialties, or facilities, which cannot be provided by “San Marcus”. When recruiting to expand this medical specialist network, “San Marcus” targets experiences, community based, board certified physicians with established patient bases and networks. San Marcus Research Clinic has access to a variety of qualified patients who are motivated to participate as study subjects. South Florida, in particular, Miami-Dade County has a high number of desirable multi-ethnic patients. Through our individualized and personalized attention, subjects are drawn in through our community outreach programs that include: telemarketing, radio announcements, Newspaper advertisement, and presentations to special groups, press release, schools, churches, and assisted living facilities.

Service Summary

San Marcus is a high quality research organization that provides reliable, superior quality services to the pharmaceutical and biotechnology industries. It is dedicated to conduct phase I – IV and OTC clinic trials and outcome integration for the young and elderly patient. One of its objectives is the advancement of fundamental knowledge for the alleviation of disease and promotion of health. Our Core Team of board certified physicians (totaling 12) and their broad spectrum of specialties bring compliment of expertise and a high number of desirable multiethnic patients under one

• rganization. Each physician has a private clinic and a team of health care professionals and is on

the staff of more than one hospital. All the clinics are within a five-mile radius of the designated clinic for the conduct of a clinical research activities. All associates have the research experience that allows clinical studies receive individual attention and flexibility to meet your special needs

Site Presentation Letter Are you familiar with our capabilities? Here is a brief look…

• 1. A dedicated research team composed of 12 M.D., 1 Ph.D. and 6 coordinators, 3 RN, 2

LPN, Pharmacist, Respiratory Technician

• 2. Available subject pool.
• 3. Bilingual personnel.
• 4. Dedicated Recruiter.
• 5. Supportive Ancillary Services.
• 6. Staff is trained in GCP’s and has outstanding SOP’s.
• 7. Dedicated Pharmacokinetic unit.
• 8. Monitored (temp) dedicated study drug room.
• 9. DEA licensed facility.
• 10. HIPPA complaint and site has its own HIPPA.
• 11. Utilized central and local IRB.
• 12. Has a local Lab.
• 13. In close proximity to 3 Hospitals (within 3-5 miles).
• 14. Rapid turn around in Regulatory and Queries.
• 15. Spacious and secured study Record Room on site.
• 16. Availability of equipment for study conducts (ECG, ABPM, blood pressure machine,

refrigerated centrifuge, regular centrifuge, -20 degrees freezer,-86 degrees freezer, regular freezers, etc.) . Therapeutic Experience is based on the range of investigators’ specialties making it accessible to match your needs.

• Allergy •Angina •Analgesics •Anesthesia •Antibiotics •Arthritis •Asthma
• Benign Prostate Hyperplasia •Birth Control Pills/Devices •Cardiology •Dermatology
• Endocrinology •Gastroenterology •Geriatrics •Hypertension •Hyperlipidemia •Insomnia
• Internal Medicine •Medical Devices •Menopause •Musculoskeletal •Neurology
• Nutrition/Metabolism •Osteoporosis •Psychiatry (anxiety, depression) •Pulmonary Medicine
• Renal Dysfunction •Rheumatology •Urinary Tract Infection •Urology

Site Presentation Letter Our Services for Phase I – IV include

• Accessible investigators with large base of private practice patients
• Community outreach speed recruitment
• Proactive enrollment program that identifies patients prior to study initiation
• All clinical research services are accessible through one point of contact
• Strict quality assurance according to standard operation procedures
• Design source documents for information gathering and data accuracy
• Rapid and accurate data reporting and entry
• Total commitment to excellence through quality, flexibility, responsiveness, communication

and timelines. MISSION

• To facilitate the research and development of new therapeutics in a high standard of quality

with a dedicated commitment and the timely responsiveness for the clients’ needs.

• To achieve the clients’ goals with efficiency, cost effectiveness, integrity and compassion. It is

integrating the experience of yesterday into the knowledge of today.

• To view all clients as partners and be committed to their success as well as ours.
• To provide the highest quality and satisfaction through research and education to the total life

needs of patients and employees.

• To treat patients with considerations and respect and maintain effective communications and

cooperative relations that exceeds their expectations.

• To develop and maintain productivity and growth through continuous innovations and the

application of appropriate technologies for the advancement of health care.

• To actively play a role in the continuing education of doctors, pharmacists, medical assistants,

educators, heath care professionals, and patients. I hope this gives you a glimpse that we are viable site for the conduct of the study. We are excited to become a partner in your research efforts towards these challenging projects .

San Marcus closely works with local and central IRB’s. All contacts and discussions are confidential. For additional information contact the Business/Clinical Director and Vice President: Manuel Peralta or the President, Jesus Reyes at (305) 424-7420 or (305) 424-7427 (fax).