West Orange Endocrinology Research Department
The staff at West Orange Endocrinology (WOE) are commitment to serve the community by offering the latest in treatment modalities and to become the leader in endocrine research in Central Florida. WOE is dedicated to improving the process of delivering services that enhance patient outcomes. Dr. Jose M Mandry has been in the greater Orlando area since 1989, involved in research since early 1990, and has been the Principal Investigator of research studies since 2010.
We Care
Our research organization was founded on the principle of advancing medical care for patients who struggle with disease.
Our clinical research studies provide a way for patients to receive treatment and education about their disease in a very cost effective way. There is no cost to participate and all product and testing is provided by the sponsor company. Patient participants have access to newest drugs and devices available when they contribute in a clinical study.
Clinical Care & Safety
For any new drug or device to be approved for sale by the FDA, there must be extensive testing. This testing is done in many phases.
At West Orange Endocrinology Research Department, we only focus on clinical trials where all safety phases have been completed so that there is minimal risk to patients.
Our clinical studies show how effective a new product performs compared to a gold standard or similar treatment.
Clinical Research
Endocrinology and metabolic studies are recognized as part of a universal core objective in understanding the process of mitigation, health maintenance and/or treatment of chronic diseases.
WOE is dedicated to mitigating the devastating effects resulting from diabetes, obesity, hypertension, metabolic diseases and lipid disorders. Together, and in conjunction with renowned scientists, academia, and specialists from other research institutes, WOE, P.A. Clinical Research contributes to advances in this field of medical research.
WOE, P.A. investigators have been involved in international conferences, scientific meetings and important forums highlighting recent research projects and presenting scientific publications. Association among professionals in research encourages stimulating discussions while sharing vital information with colleagues. Our experiences and accomplishments have been published in full scientific journals. These investigations exceptionally impact regional and international standards of practice through new discoveries and developments.
With increasing maturity, experience and associations in the industry, we have evolved into industry-sponsored (ISRs) programs. At WOE, P.A. our associations with the Clinical Research Organization (CRO) and pharmaceutical industries, WOE, P.A. has become well recognized because of the commitment demonstrated in collaboration with CRO to a successful clinical trial program.
As we grow and embark on new research programs, we continue to develop and culminate the optimal culture for good clinical practices in research. Compliance with GCP, safety and optimization treatment of our clients are the main goals. We are honored to be of service to the community to offer new products and opportunities to our patients and to provide meaningful information to other scientists, physicians and research investigators.
Our team of qualified staff members maintain a low failure rate for screening patients and for lost to follow-up. Our staff keeps subjects on tract with frequent phone reminders and messages. We have a high enrollment in studies and reach or surpass our expectations. Some of our studies have been capped early due to high enrollment. We are proud to have high enrollment, good retention as well as good quality data.
Our Clinical Research Team
Dr. Jose Mandry M.D.
Principal Investigator
Maria Mandry, PA-C
Sub - Investigator
Dr. Oscarina Herrera, M.D.
Sub - Investigator
Mary Mandry, MS, RD, LD/N
Site Administrator
Dr. Maria Marulanda, M.D.
Sub - Investigator and Lead Clinical Research Coordinator
Dr. Ineska Marulanda, M.D.
Clinical Research Coordinator
Sponsors and CRO
West Orange Endocrinology has developed an excellent working relationship with different sponsors and CRO in the United States.
We conduct Phase II, III & IV studies to support requirements leading to new drug applications.
What We Offer
-
West Orange Endocrinology research department is a reputable and well recognized site by clinical research organizations and leading pharmaceutical companies, meeting or exceeding recruitment and retention targets with a high degree of protocol compliance and data quality. Our priority is the well-being and safety of the patients.
-
West Orange Endocrinology research department provides a team of experienced professionals and doctors committed to excellent pharmaceuticals research with a personal touch.
-
West Orange Endocrinology research department offers clinical pharmacology services in Phases II, III, IV.
Team Credentials
- All staff is GCP certified
- PI: Jose Mandry, >20 years of experience
- Clinical Site Manager, >10 years of experience
- CRC’s, 10-25 years of experience
- On-site licensed ACLS
- 3 full-time patient recruitment staff members
- 1 Regulatory Specialists
- Phlebotomist with IATA certification
- 1 licensed Dietician
WOE Facility Amenities
- Secured, locked, limited access ambient drug room locked with limited access, refrigerator; limited access.
- -20 degree freezer
- Onsite lab with sample collection and shipping
- Use central lab, ability to use Local clinical laboratory for safety and STAT results,
- Dry ice available
- Security system with alarm and cameras
- Private room for consenting
- 1 room for monitor visits with Wi-Fi.
- Dedicated exam room.
- On-site storage for closed study files
- On-site access to physicians
- Local hospital only 0.4 miles away
- Parking Lot
WOE Equipment
- -20 freezer
- Incubators
- Ambient and refrigerated drug storage on site
- Temperature monitoring
- Ambient centrifuge
- Accurate certified patient scales
- 12 lead ECG units
- Pulse oximetry units
- Scale to weigh study drug
- Glucose monitoring system
- Electronic Blood pressure equipment
- Back-up generator
- Back up Refrigerator
- IV infusion pump
- **All equipment is calibrated every 12 months or less.
Volunteer Recruitment
Our dedicated recruitment staff maintains an ever-expanding and detailed database continually updated and replenished through Dr. Mandry’s daily patients, referrals from advertisements, private practices, and recruitment websites, that allows us to access suitable volunteers based on important demographic input that encompasses all major groups for volunteer populations.
WOE Central Labs
- Quintiles
- Covance
- MedPace
- Quest
- Lab Corp
WOE Source
- West Orange Endocrinology research department has developed valuable source documents, which are designed and tailored to follow the visit process ensuring all viable trial data is captured for the sponsor.
- Also, all source documents are kept in a color code hard 3-ring binder which is labeled appropriately from informed consent to adverse events; this is to ensure consistency and accuracy.
- A typical patient source binder would have the following labels: 1. Demographics 2. Informed consent 3. Medical history- which is signed by Principal Investigator and signed. 4. Concomitant Medications 5. Flow Sheet 6. Adverse event / SAE. 7. Visits according to protocol 8. Lab reports/ ECG’s
Sponsors
- Eli Lilly
- Boehringer Ingelheim
- AstraZeneca
- Sanofi
- Kowa
- AbbVie
- Anji Pharma (US) LLC
- Radius Health, Inc.
- Teijin America, Inc.
- CSL Behring LLC
- Lexicon Pharmaceuticals