San Antonio, Texas 78205
(210) 340-5646 http://www.paragonresearch.org esanchez@paragonresearch.org
Visit our website at www.paragonresearch.org
Paragon Research Center is a physician owned state of the art research center designed to conduct phase II, III, and IV studies in primary care and neurology for pharmaceutical and CRO sponsors. It is a dedicated research center with 3 fulltime certified coordinators, 2 fulltime research assistants, 2 part time certified dieticians, 1 fulltime administrative assistant and a fulltime administrator. The intimate staff size allows for personalized attention to our customers, our sponsors and our research volunteers. The PI provides daily hands on oversight of all research activities. The PI reviews all study protocols with the coordinators prior to participation and they together, decide on feasibility to perform the study and if the study goals are achievable. If participation is agreed upon, two coordinators are assigned to the study one as the lead, the other as back-up. One of these coordinators completes the regulatory documents with a turn around time of 3 to 5 business days. The administrator handles the budget and the contract with oversight by Dr. Poss and a turn around time of 3 to 5 business days. The PI and the lead coordinator attend the investigators meeting and then in-service the appropriate personnel about the protocol, designated duties, all known safety data and side affects of the study drug prior to study start. The principle investigator oversees the selection of trial subjects, the informed consent process, and monitors participants' safety during the study, signs all lab and EKG's, x-rays, reviews all adverse events and study documents and performs all required protocol related procedures. One of the important strengths of Paragon Research Center is the active involvement of the PI.
Our goals are as follows:
- Perform, maintain and excel in providing high quality, reproducible research results and hold ourselves and our staff to the highest standards in medical and research expertise.
- Play an integral role in contributing to our future's new and innovative pharmaceuticals therapies being approved by the FDA and made available to the intended recipients.
- Take complete responsibility for the services we provide and or delegate as we conduct clinical trials and keep study participant safety and compliance with good clinical practices a top priority.
- Understand and tend to the needs of our customers, the pharmaceutical companies and study participants, and maintain vigilance regarding the importance of personalized attention to both of them.
Create a stable enjoyable working environment for our staff that promotes commorodore, team play, a desire to help one another in addition to self achievement, growth, and fulfillment.
Paragon Research Center was created in 2007 by Dr. Geri Poss. Dr. Poss had originally found Innovative Clinical Trials in 2003 with a neurologist and internist partner. Both organizations remain together at the same location and all 3 investigators work on trials together. Paragon Research Center is a dedicated research center and is solely owned and managed by Dr. Poss.
Paragon Research Center specializes in primary care research and also participates in many neurology studies. PRC's main areas of research are in obesity, smoking cessation, insomnia, chronic non-malignant pain such as low back pain, osteoarthritis, migraines, peripheral neuropathy; hypertension, dyslipidemia, metabolic syndrome, COPD, tremors, and restless leg syndrome. The site conducts approximately 20 to 25 studies per year and has experience in conducting over 80 clinical trials. All coordinators are licensed nurses, have a minimum of 5 years experience each in performing clinical trials, are certified by ACRP or CCRP, and are all HAZMAT and IATA certified. They are required to attend the monthly GCP and SOP training offered at the center and must complete CME requirements for ongoing research certification. All principle investigators at PRC are also certified by ACRP, certified by their medical specialty Board, must attend the monthly GCP and SOP training and must complete CME requirements for continued ACRP and medical board certification. All coordinators are experienced with IVRS systems (UBC, ICON, RAMOS) and EDC (Medidata, Inform, PDS).
Each month there are 3 mandatory weekly meetings of the research staff. One meeting focuses on recruitment and retention strategies for each trial along with reviewing all adverse events, IND safety reports, and achieved metrics. The other meeting is an internal audit of research charts and regulatory binders for compliance with protocol, SOPs, and FDA, ICH-GCP guidelines. The third meeting as previously mentioned is training on GCP and Paragon's SOPs.
We specialize in trials for:
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Obesity Smoking Cessation Insomnia Chronic Pain Low Back Pain Osteoarthritis Hypertension |
Hypercholesterolemia Metabolic Syndrome Diabetes Mellitus Tremors Restless Leg Syndrome Migraines |
Sponsors / CRO's / IRB Clinical Trial participation is as follows:
Sponsors
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Abbott Adams Amylin Astellas AstraZeneca Bristol- Myers- Squibb DOV Pharmaceuticals Glaxco-Smith-Kline |
Johnson & Johnson Lilly Luitpold Mitsubishi Mylan Bertek Myogen Novartis Pfizer |
Pharmacia Pliva Purdue Sanofi-Aventis Shinogi Takeda Vivus Xenoport |
Contract Research Organizations (CRO's)
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B & B Clinical Innovations Covalent Covance Ingenix |
Medpace OmniCare Pharmaceutical Research Corporation PPD |
PRA Quintiles Scirex Spectrum |
Institutional Review Boards (IRB's)
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Chesapeake Research Review, Inc. Coast IRB Copernicus Group IRB Goodwyn IRB |
IntegReview IRB New England IRB Quorum IRB Research Consultants Review Committee IRB |
Schulman & Associates IRB Sterling IRB Western Institutional Review Board |
- Board Certified Family Practice
- Certified Clinical Trial Investigator
- Experience List
- Visit our website @ www.paragonresearch.org
A graduate of the University of Texas at San Antonio, Dr. Poss obtained her medical degree in 1982 at the University of Texas Medical Branch at Galveston, Texas. She completed her residency in Family Practice at the Santa Rosa Family Practice Residency Program. Dr. Poss has been in private practice in San Antonio since 1984. She is past president of the Alamo Chapter of Family Physicians and past Chief of Staff at Village Oaks Regional Hospital (now Northeast Methodist). She has actively been involved in clinical research since 1999 and is a member of ACRP and is a Certified Clinical Trial Investigator. Her special areas of interest are in obesity, smoking cessation, chronic pain (especially lower back pain), migraine headaches, insomnia, hypertension, elevated cholesterol, diabetes, osteoarthritis, and restless leg syndrome..
Elizabeth Sánchez, Administrator
Active in the healthcare management arena since 1978. Her medical background originated in the United States Air Force. She has managed several large multi-specialty physician groups with doctors practicing primary care, pediatrics, radiology, urgent care, orthopedics, and orthopedic oncology, peripheral vascular and general surgery.
Her areas of expertise include negotiating clinical trial budgets and agreements, marketing, practice management, clinic operations, and project development. She has been involved with clinical research since 2007.
Lois Robinson, LVN, CCRC, Director of Research Affairs
Active in the health care field since 1970 and in research since 2002. As a nurse she specialized in Family Practice and Geriatric Medicine. As a Certified Clinical Research Coordinator she has managed Phase II-IV studies in the following therapeutic areas: primary care, neurology, endocrinology, gastroenterology and pulmonologist. She is the Director of Research Affairs and lead coordinator for
Crystal Rosemann, RN, CCRC, Lead Coordinator
She practiced as a registered nurse from 1991 to 1997, and then became active in clinical research. Crystal has extensive experience as a Certified Clinical Research Coordinator for studies in oncology, dermatology, and primary care. She is a lead coordinator for Paragon Research Center.
Nirmala Auerbach, RD, LD, Registered Dietician
Nirmala ("Nimi") Auerbach, RD, LD is a registered dietician licensed to practice in the State of Texas. She obtained a Master's Degree in human nutrition after completing an internship in dietetics from the Henry Ford Hospital in Detroit, MI. Nimi's research experience includes participation in studies conducted by the Center of Disease control (CDC), the American Pediatric Association, American Dietetic Association and Ph II-IV Obesity Clinical Trials. She is an active professional member of the American Dietetic Association, the San Antonio Dietetic Association and the Texas Dietetic Association.
Maria Castellano, Executive Assistant
Active in the health care industry for the past ten (10) years. She serves as receptionist and executive assistant for Paragon Research Center.
As the receptionist, she schedules appointments for all the coordinators and keeps track of all the volunteer's visits and financial reimbursements.
As executive assistant, she coordinates database management, word processing, and other duties that streamline the day-to-day operations of the organization..
Stephanie Ford, MA, CRA, Assistant Research Coordinator
Active in the health care industry since 1996 with experience in family practice, internal medicine, ob/gyn and orthopedic spinal medicine. Her clinical research experience began in early 2007. She has experience in clinical trials on obesity, diabetes, hypertension, neuropathy, insomnia, restless leg syndrome, metabolic syndrome and Alzheimer's disease.
As an assistant coordinator, her duties include working alongside the lead coordinator, performing daily subject visits, completing source documents, and consenting & screening subjects for studies.
Angela Castro, MA, Research Assistant
Active in research since 2004. She draws and processes the lab work and performs the EKG's on volunteers at Paragon Research Center. She is responsible for filing, preparing the charts for volunteers, and keeping regulatory information up to date.
The San Antonio metropolitan area has 1.5 million people. This includes Bexar, Comal, Guadalupe and Wilson counties. At least half of this population is Hispanic, 72% are over the age of 18 with almost equal female and male distribution. A large portion of the population is retired military. Our pollen season is year round due to our mild climate and diabetes, hypertension, arthritis, heart disease and obesity are major health concerns.
Cardiology/Vascular Diseases
Neurology
Obstetrics/Gynecology
Pulmonary/Respiratory Diseases
Paragon Research Center is located in downtown San Antonio in the historical area of St. Paul Square with easy access from 281. The San Antonio Airport is an easy 10 minute drive from our location. PRC was designed exclusively to conduct Phase II, III, and IV clinical trials. A home environment was created by having the waiting room appear as a living room and the bathroom is residential style. Research volunteers are offered cappuccino, coffee, tea, soft drinks, bottled water, and light snacks. Each coordinator at PRC has their own private office to meet confidentially with volunteers. The office has access to 5800 square feet with two private monitor rooms each with data ports and phone lines. The exam rooms are well equipped with calibrated weight scales, mobile mercurial sphygmomanometers for blood pressure assessments and EKG machines. The lab is CLIA certified and has a calibrated centrifuge, a temperature monitored -20 degree Celsius refrigerator and a temperature monitored standard refrigerator. Dry ice is readily available. The site provides phlebotomy, oximetry, EKG, NCV, UA, microscopy analysis, urine pregnancy test, HgA1C, glucose, CO2 levels, skin biopsies and any protocol required minor surgical procedure.
The double locked drug storage room has its own temperature monitor controls to maintain the ambient temperature required for the study drug. This drug room also meets federal standards for the storage of controlled substances.
Elizabeth Sanchez
Administrator
Paragon Research Center
1148 E. Commerce St.
San Antonio, TX 78205
USA
(210) 340-5646
(210) 692.9145 (fax)
esanchez@paragonresearch.org
www.paragonresearch.org