Miami Research Associates continues to grow and offer enhanced R&D services. Contact Teresa Wright for more information on how we can help you execute your next early or late stage clinical trial.
MRA can successfully conduct your next research study!Teresa Wright CCRP
Miami Research Associates continues to grow and offer enhanced R&D services. Contact us for more information on how we can help you execute your next early or late stage clinical trial.
Оптимизация лечения ВИЧ в 2018 году / HIV Treatment Optimization: 2018hivlifeinfo
HIV Treatment Optimization: 2018
In this downloadable slideset, Eric S. Daar, MD, provides a comprehensive update on ART management.
Format: Microsoft PowerPoint (.ppt)
File Size: 723 KB
Released: April 26, 2018
In the era of modern technology, health care delivery system involves so many different personnel and specialties that the caregiver must have an understanding and working knowledge of other professional endeavors, including the role of diagnostic evaluation.
Basically, laboratory and diagnostic tests are tools by and of themselves, they are not therapeutic.
In conjunction with a pertinent history and physical examination, these tests can confirm a diagnosis or provide valuable information about a patient status and response to therapy.
In addition to these, laboratory findings are essential for epidemiological surveillance and research purposes.
If the entire network of a laboratory service is to be effectively utilized and contribute to health care and disease prevention, every member of its work force need to:
Understand the role of the laboratory and its contribution to the nation’s health service;
Appreciate the need to involve all members in the provision of health service;
Follow professional ethics and code of conduct;
Experience job satisfaction and have professional loyalty.
Medical laboratory science is a complex field embracing a number of different disciplines such as
Microbiology,
Hematology,
Clinical Chemistry,
Urinalysis,
Immunology,
Serology,
Histopathology,
Immunohematology and
Molecular biology and others
MRA can successfully conduct your next research study!Teresa Wright CCRP
Miami Research Associates continues to grow and offer enhanced R&D services. Contact us for more information on how we can help you execute your next early or late stage clinical trial.
Оптимизация лечения ВИЧ в 2018 году / HIV Treatment Optimization: 2018hivlifeinfo
HIV Treatment Optimization: 2018
In this downloadable slideset, Eric S. Daar, MD, provides a comprehensive update on ART management.
Format: Microsoft PowerPoint (.ppt)
File Size: 723 KB
Released: April 26, 2018
In the era of modern technology, health care delivery system involves so many different personnel and specialties that the caregiver must have an understanding and working knowledge of other professional endeavors, including the role of diagnostic evaluation.
Basically, laboratory and diagnostic tests are tools by and of themselves, they are not therapeutic.
In conjunction with a pertinent history and physical examination, these tests can confirm a diagnosis or provide valuable information about a patient status and response to therapy.
In addition to these, laboratory findings are essential for epidemiological surveillance and research purposes.
If the entire network of a laboratory service is to be effectively utilized and contribute to health care and disease prevention, every member of its work force need to:
Understand the role of the laboratory and its contribution to the nation’s health service;
Appreciate the need to involve all members in the provision of health service;
Follow professional ethics and code of conduct;
Experience job satisfaction and have professional loyalty.
Medical laboratory science is a complex field embracing a number of different disciplines such as
Microbiology,
Hematology,
Clinical Chemistry,
Urinalysis,
Immunology,
Serology,
Histopathology,
Immunohematology and
Molecular biology and others
Back to the Bedside: Internal Medicine Bedside Ultrasound ProgramAllina Health
David Tierney, MD. How bedside ultrasound is changing the practice of medicine and how Abbott Northwestern Hospital has become a national leader in integrating bedside ultrasound in its Internal Medicine Residency Program. "As internal medicine physicians, we are finding that everything we do with our hands, eyes and stethoscopes can be done a little better with ultrasound. That means our physical exam, which we consider our bread and butter, has more sensitivity and specificity. This gives us better diagnostic ability and results in earlier and more appropriate treatment."
Larkin Community Hospital is a 146 Bed Acute Care Teaching Hospital located in South Miami, Florida. This slide show provides a glimpse into this hospital system highlighting graduate medical education.
Using real-world evidence to investigate clinical research questionsKarin Verspoor
Adoption of electronic health records to document extensive clinical information brings with it the opportunity to utilise that information to support clinical research, and ultimately to support clinical decision making. In this talk, I discuss both these opportunities and the challenges that we face when working with real-world clinical data, and introduce some of the strategies that we are adopting to make this data more usable, and to extract more value from it. I specifically discuss the use of natural language processing to transform clinical documentation into structured data for this purpose.
QPS is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. We provide quality services to pharmaceutical and biotechnology clients worldwide.
Point of Care Testing (POCT) refers to medical testing that is conducted outside of a laboratory setting, typically near or at the location of a patient. This can include testing in a physician's office, at home, in the field, or in a hospital room. POCT is usually performed using portable, handheld, or small benchtop devices. Here are some main features and advantages of POCT:
Convenience and Speed: Since POCT can be done at or near the patient's location, it eliminates the need to send samples to a lab and wait for the results. This can result in quicker diagnosis and treatment.
Immediate Decision Making: With instant results, healthcare providers can make immediate decisions about a patient's care, leading to improved patient outcomes.
Reduced Costs: While some POCT devices can be expensive, they may reduce overall healthcare costs by shortening hospital stays, reducing the number of follow-up visits, and preventing complications.
Simplicity: Many POCT devices are designed to be user-friendly, allowing non-laboratory personnel or even patients themselves to conduct tests.
Connectivity: Modern POCT devices often come with connectivity options, enabling the integration of test results into electronic health records.
Versatility: There's a wide range of tests available for POCT, from blood glucose testing to rapid strep tests and coagulation tests.
However, it's also important to note some challenges with POCT:
Quality Control: Ensuring the accuracy and reliability of POCT results can be challenging, especially if tests are being conducted by non-laboratory personnel.
Cost: Some advanced POCT devices can be costly, and there may be additional costs associated with training and quality control.
Regulation and Oversight: Because POCT is performed outside of the traditional lab setting, there can be challenges related to oversight, regulation, and ensuring that tests meet necessary standards.
In summary, while POCT offers many advantages in terms of speed and convenience, it's essential to ensure that tests are accurate, reliable, and meet necessary standards.
Rapid diagnostic tests (RDTs) in India play a crucial role in the detection and management of various diseases, including infectious diseases like malaria, dengue, and more recently, COVID-19. Here's an overview of RDTs in India:
Importance in Disease Management: In a vast and diverse country like India, with varied healthcare infrastructure across its regions, RDTs provide a quick and effective way to diagnose diseases, especially in remote areas where sophisticated laboratory setups might not be available.
Malaria and Dengue Detection: RDTs for malaria (based on the detection of antigens produced by malaria parasites) and dengue (based on the detection of dengue NS1 antigen and anti-dengue antibodies) are widely used. They offer results in less than
Rapid Diagnostic Tests (RDTs) in India play a crucial role in the quick detection and diagnosis of various diseases. They are espec
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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Similar to MRA can successfully conduct your next research study; see how!
Back to the Bedside: Internal Medicine Bedside Ultrasound ProgramAllina Health
David Tierney, MD. How bedside ultrasound is changing the practice of medicine and how Abbott Northwestern Hospital has become a national leader in integrating bedside ultrasound in its Internal Medicine Residency Program. "As internal medicine physicians, we are finding that everything we do with our hands, eyes and stethoscopes can be done a little better with ultrasound. That means our physical exam, which we consider our bread and butter, has more sensitivity and specificity. This gives us better diagnostic ability and results in earlier and more appropriate treatment."
Larkin Community Hospital is a 146 Bed Acute Care Teaching Hospital located in South Miami, Florida. This slide show provides a glimpse into this hospital system highlighting graduate medical education.
Using real-world evidence to investigate clinical research questionsKarin Verspoor
Adoption of electronic health records to document extensive clinical information brings with it the opportunity to utilise that information to support clinical research, and ultimately to support clinical decision making. In this talk, I discuss both these opportunities and the challenges that we face when working with real-world clinical data, and introduce some of the strategies that we are adopting to make this data more usable, and to extract more value from it. I specifically discuss the use of natural language processing to transform clinical documentation into structured data for this purpose.
QPS is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. We provide quality services to pharmaceutical and biotechnology clients worldwide.
Point of Care Testing (POCT) refers to medical testing that is conducted outside of a laboratory setting, typically near or at the location of a patient. This can include testing in a physician's office, at home, in the field, or in a hospital room. POCT is usually performed using portable, handheld, or small benchtop devices. Here are some main features and advantages of POCT:
Convenience and Speed: Since POCT can be done at or near the patient's location, it eliminates the need to send samples to a lab and wait for the results. This can result in quicker diagnosis and treatment.
Immediate Decision Making: With instant results, healthcare providers can make immediate decisions about a patient's care, leading to improved patient outcomes.
Reduced Costs: While some POCT devices can be expensive, they may reduce overall healthcare costs by shortening hospital stays, reducing the number of follow-up visits, and preventing complications.
Simplicity: Many POCT devices are designed to be user-friendly, allowing non-laboratory personnel or even patients themselves to conduct tests.
Connectivity: Modern POCT devices often come with connectivity options, enabling the integration of test results into electronic health records.
Versatility: There's a wide range of tests available for POCT, from blood glucose testing to rapid strep tests and coagulation tests.
However, it's also important to note some challenges with POCT:
Quality Control: Ensuring the accuracy and reliability of POCT results can be challenging, especially if tests are being conducted by non-laboratory personnel.
Cost: Some advanced POCT devices can be costly, and there may be additional costs associated with training and quality control.
Regulation and Oversight: Because POCT is performed outside of the traditional lab setting, there can be challenges related to oversight, regulation, and ensuring that tests meet necessary standards.
In summary, while POCT offers many advantages in terms of speed and convenience, it's essential to ensure that tests are accurate, reliable, and meet necessary standards.
Rapid diagnostic tests (RDTs) in India play a crucial role in the detection and management of various diseases, including infectious diseases like malaria, dengue, and more recently, COVID-19. Here's an overview of RDTs in India:
Importance in Disease Management: In a vast and diverse country like India, with varied healthcare infrastructure across its regions, RDTs provide a quick and effective way to diagnose diseases, especially in remote areas where sophisticated laboratory setups might not be available.
Malaria and Dengue Detection: RDTs for malaria (based on the detection of antigens produced by malaria parasites) and dengue (based on the detection of dengue NS1 antigen and anti-dengue antibodies) are widely used. They offer results in less than
Rapid Diagnostic Tests (RDTs) in India play a crucial role in the quick detection and diagnosis of various diseases. They are espec
Similar to MRA can successfully conduct your next research study; see how! (20)
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Evaluation of antidepressant activity of clitoris ternatea in animals
MRA can successfully conduct your next research study; see how!
1. M I A M I R E S E A R C H A S S O C I A T E S
“Making a Difference for the Future”
2. 2013…
MRA Joins QPS
Full Service CRO Early Stage Operations:
India
Taiwan
Netherlands
Springfield, MO
Toxicology, Pre-Clinical, Bioanalysis, Biomarkers:
Delaware
3. MRA Operations
MRA Primary Campus
Phase I Center
Broward Research Group (Sister Site)
Sleep Centers (Broward & Miami-Dade)
Patient Recruitment Advertising Agency
MRA Clinical Laboratory
4. Current Overview
MRA conducts approximately 75 trials/year
Over 1500 trials successfully conducted since
1996
Nearly every therapeutic area except
Oncology
Preferred provider agreements with Pfizer,
Sanofi and several major CRO’s
Last 4 FDA audits did not result in a Form 483
5. Phase I Unit Directors
Dr. Patricia Pardo
Dr. Martha Hernandez-Illas
Anesthesiology
Dr. Michael Meister
Dr. Guillermo Pol
Cardiology
Dr. Harry Aldrich
Dr. Abbe Rosenbaum
Dermatology
Dr. Georgette Rodriguez
Gastroenterology
Dr. Harris Goldberg
Dr. Howard Schwartz
Neuroscience
Psychiatry
Dr. Americo F. Padilla
Neuropsychology
Rafael Rivas-Vazquez, Psy.D.
Gustavo J. Rey, PhD
Neurology
Dr. Bruce Kohrman
Nutrition/Endocrinology
Dr. Diane Krieger
Dr. Douglas S. Kalman
Ophthalmology
Dr. Ann Elizabeth Ballen
Pediatrics
Dr. Adriana Castro
Pulmonary
Dr. Jeremy Tabak
Rheumatology
Dr. Jaime Pachón
Dr. Eric Sheldon
SSppeecciiaallttyy
IInnvveessttiiggaattoorrss
Sleep Disorders
Dr. David Seiden
Dr. Howard Schwartz
Dr. Timothy Grant
Urology
Dr. John Mekras
Vaccines
Dr. Eric Sheldon
Women’s Health
Dr. Robert Feldman
6. Research Staff
Overview
MRA has 150 employees, 40 of
whom are ACRP-certified CCRC’s,
and has a very low employee
turnover rate
Our Senior Research Coordinators
have an average of 8 years of
experience
Our dedicated staff has been an
integral part to the company’s
success
7. Association for the Accreditation of
Human Research Protection
Programs (AAHRPP)
MRA is one of only two non-academic
clinical research centers
to receive this prestigious
recognition
Accredited Since 2010
Human Subject
Protection
9. Investigators:
Timothy Grant, MD. & David Seiden, MD.
Location:
Miami Research Associates & Broward Research Group
Study Indications:
Equipment
Chronic Insomnia
Delayed Sleep Phase
Syndrome
Driving Simulation
Elderly Insomnia
Jet Lag
Narcolepsy in Children
Non-restorative Sleep
Pediatric ADHD Insomnia
Primary Insomnia
Restless Leg Syndrome
Shift Work
Sleep Apnea
Transient Insomnia
MRA
Sleep
Department
10 beds
Polysomnography equipment by GRASS Technology
Operation is a joint venture between MRA and Baptist Health Systems
BRG
9 beds
Polysomnography equipment by GRASS Technology
Operation is a joint venture between MRA and Baptist Health Systems
1999: Dr. David Seiden, Board-Certified Neurologist
and Sleep Specialist, Dr. Timothy Grant, Board-Certified Neurologist and Sleep
Specialist, began conducting Insomnia studies with Dr. Howard Schwartz and
Miami Research Associates
2001: Drs. Seiden founded the Broward Research Group (BRG) and the
Broward Sleep Division; today BRG is a privately owned multi-specialty clinical
research center
in Fort Lauderdale
10. Investigator: Howard Schwartz, MD
Study Indications:
GERD
IBS
Hep C
Crohns
UC
Hepatic Safety
Endoscopy Safety
H Pylori
Gastroenterology
Department
Equipment
Endoscopy
Liver Biopsy
Colonoscopy
Dr. Howard Schwartz belongs to
GI practice with 14 doctors.
11. Investigators:
Eric Sheldon, MD & Jaime Pachon, MD
Study Indications:
Osteoarthritis – Knee, Hip, Spine
Rheumatoid Arthritis
Narcotic Pain Trials
Equipment
Analog Hybrid Digital X-Ray Machine
Muscle Skeletal Ultrasound machine for diagnostic
and procedure guidance
Rheumatology
Department
Participated in trials for the following
marketed drugs:
Participated in Phase 1 Trials
thru IV using IV infusions / SQ Injections/Oral
Screening/Enrollment
2012 a total of 7 Rheumatoid Arthritis trials were
performed including a phase 1 and an automatic
injector device trial
Enrollment total screened 121
Randomized 91
12. Psychiatry
Department
> 15 years of experience with over 100 clinical trials
> 4 Investigators
2 Psychiatrists
2 Psychologists
> 3 Coordinators
2 Certified Coordinators with more than 7
years of experience
1 Coordinators with more than 4 years of
experience
1 Assistant Coordinator with more than 2 years
Investigator: Americo F. Padilla, MD
Study Indications: Phase 1 to IV Trials
Adults
• Depression (Phase I, II, & III)
• Schizophrenia (Phase II & III)
• Eating Disorder, Binge (Phase III)
Children and Adolescents
ADHD (Phase I, II, & III)
PK Studies (Phase I)
Classroom Studies
Narcotic Pain Trials
Screening/Enrollment
Standard enrollment target of 10-20 patients per trial
History of being a high enrollment site
Access to the Hispanic population
Expertise in Scale Administration
• MINI
• K-SADS-PL
• ADHD-RS-IV
• CSSR-S
• HAM-A
• HAM-D
• MADRS
• CGI-I/S
• SCID
• ATRQ
• SDS
• BARS/AIMS/SAS
Psychiatry Team
14. Investigator: Robert Feldman, MD.
Women’s Health
Department
Screening/Enrollment
In complex, multiprocedural studies with frequent
visits, we have an compliance/retention rate
approaching 100%
Enrolled 1500 subjects in Pap/HPV testing trail and
followed 300 subjects in a 3 year colposcopy study
15. Investigator: Diane R. Krieger, MD
Douglas S. Kalman, PhD, PI and RD- Director Business
Samantha Feldman, MS, RD, CCRD- Special Projects
Nutrition
Department
Nutrition/Endocrinology Division
Pharmaceutical Studies
OTC
Medical Nutrition Therapy Products
Nutritional Product Studies
Dietary Supplement
Functional Food
Raw Material
16. Pulmonary
Allergy
Asthma
WPD
Smoking Cessation
Cardiology
High blood pressure
A fib
PVD
Hyperlipidimia
Other
Departments
Urology
BPH
Sexual Dysfunction
Ophthalmology
Safety Studies
18. Investigator: Diane Krieger, MD
Lab Managers: Sonia Torres & Maria Alarcon
Study Indications: Clinical Lab
Chemistry: CMP, Magnesium, CK, LDH, Amylase,
Phosphorus, Lipid Panel, A1c, Uric Acid, GGT, &
NEFA
Hematology: CBC with Diff, & ESR
Special Chemistry: Serum Pregnancy, Insulin, C-Peptides,
Thyroids (T3, T4, TSH), Cystatin C, FSH,
IgE, & Testosterone
Urinalysis with Microscope exam
The MRA Lab is…
CLIA and COLA certified
Participants of American Proficiency
Institute proficiency testing service.
MRA Laboratory Management:
Evaluates protocol to establish laboratory needs
Attends SIV
Coordinates with resource manager to generate
calendar of events
Prepares pertinent logs & requisition forms
Prepares laboratory kits needed throughout the
study
Packs & ships specimens
Oversees sample retention
Laboratory
Department
19. Full Time Pharmacist: Vilma Vales, Pharm D
Equipment:
Pharmacy
Department
Compounding Scale
Level 2 Certified Hood
-20/-70 Degree Freezers
Alarm Guard
All Study Drug is kept in secure Pharmacy
Temperature (24/7, Min and Max Recording)
Refrigerators, -20 & -70°C Freezers
Alarm Guard
Strictly enforced limited access
Biosafety Cabinet Level 2 Certified Hood
Back-up Generator in case of power failure
21. Phase I
Overview
Conducts numerous complex studies that
other sites can’t
Uniquely offers high-level medical oversight
of special populations and healthy volunteers
Consistent in being highest enrollers
Excellent subject retention (over 90%)
Sponsor requests for additional cohorts
Multiple therapeutic areas
22. Phase I
Trial Experience
As of October 2013 our Phase I Center completed over 120 trials, including:
First-in Man
PK/PD
ECG/Cardiac Safety
Special Populations
Pediatrics
Vaccines
Food Interaction
Pharmacokinetics
Dose Ranging
Jet Lag
Polysomnography
QTc Monitoring
Endoscopic Safety
Bioavailability/Bioequivalency
23. 20,000 Square Feet
72 Active Beds
Central Nursing Station
Multiple dorms configured for
privacy, cohort mgmt.
Internet access via desktops &
Wi-Fi
Three activity areas
24-hour lab turnaround
Customized meals by
registered dietitians
Across from South Miami
Hospital
Phase I
Facility Description
Security
Cameras throughout the facility
Key Card Restricted Access
Closed-Circuit TV
Entertainment
DVDs
Video Games
Board Games
Flat panel TVs
Educational/Art Activities
24. Equipment:
Emergency Equipment:
Emergency Room located less
than 100 yards from unit
Crash Cart
Emergency Medications
2 Defibrillators
Oxygen Tank
Pull Cord Emergency Service
installed in bathrooms
Mortara Wireless Telemetry
EEG
ECG
Refrigerated Centrifuges
Echocardiogram
Endoscopy
PSG Recording
DEXA Scanner
Digital X-Ray
-70°C Freezers
Spirometry
Compounding Scale
Biosafety Cabinet Level 2 Certified Hood
Slit Lamp
Phase I
Clinical Capabilities
25. Elderly
Hepatic
Renal
Psoriasis
Type II Diabetes
Post-Menopausal
Hypertension
Obesity
Parkinson’s
Depression
Pediatric ADHD
Arthritis
o Rheumatoid
o Osteoarthritis
Lupus
Phase I
Special Populations
26. In-house Advertising Agency
Multi-media Production Capabilities
Print
Radio
Television
Internet (Web Portals/Email Marketing)
Social Media (i.e. Facebook, Twitter, YouTube)
SMS (Text Messaging)
News Releases & On-air Endorsements
Conferences/Special Events
Marketing &
Advertising
Media Buying Power
Public Relations
Campaign Response Analytics
Integrated Marketing
Database and Targeted
campaigns based on
Psychographics AIO
(Activities, Interests and Opinions)
27. Recruitment
Advertising in local media,
internet and conventional
mediums
Dedicated Call Center with state
of the art technology and
experienced staff
Guerrilla Marketing
HIPAA Compliant Database of
over 30,000 Willing Subjects
Recruitment &
Retention
Retention
Early patient education
Establish good rapport with
subjects
Frequent follow-up and
reminder contacts via phone,
emails and SMS texting
Clinical RSVP screening
28. Quality Assurance
& SiteTraining
Our QA Team; Edith Bethencourt, Ana
Soler, Linda Camp and Jose Garcia is
responsible for:
SOP Creation, Revision, and Implementation
Sponsor/FDA Audit Preparation
GCP , Research Asst., HIPAA & ACRP Exam Prep Training
Inform Study Coordinators through the “QA Tip of the Week”
Standardization
Upfront/Backend QA
Investigator Lunch & Learn Series
29. SiteTraining
MRA conducts various trainings throughout the year in order to provide our
staff with the most current knowledge available:
GCP training
Training Sessions for ACRP
Certification Exam
Research Assistant Training for new
employees
HIPAA Training
Investigator’s Lunch and Learn Series
30. Technology
High level of network security
Virtualization- On-site and off-site
2 System-tier for Internet (T1 and Cable)
Internet availability within and outside our
network
Wi-Fi for Monitor Access
Optimized Data Management
Telecommunications, including web
conferencing
Enhanced Back Up System
Higher Security including key card access,
DVR camera system throughout building
and suites
31. Our research staff EDC systems
training includes:
I*NET
Trialink
Phoenix Data Systems
Inform / Phase Forward
Flex DMS
Oracle RDC
Medidata/Rave
StudyWorks
QDS DEAS
Electronic
Data Capture
Data Entry usually occurs within
24 hours of seeing the subject
Quality Control
Subject’s source document
is reviewed prior to and
during data entry
Data Clarifications are
answered within 24 hours of
receipt
32. Conclusion
MRA excels at conducting complex clinical trials due to:
Highly-trained clinical staff
All the benefits of an academic medical center without
usual impediments at start up.
Multi-specialty physicians on-site and on-call
High Investigator Involvement
Ability to conduct trials from Phase I to IV
Access to a diverse patient population
Outstanding recruitment/retention capabilities
33. Medical Director: Howard I. Schwartz, MD
Key Contacts
• Phone: (305) 598-3125 / Email: hschwartz@miamiresearch.com
Medical Director: Eric A. Sheldon, MD
• Phone: (305) 598-3125 / Email: esheldon@miamiresearch.com
Business Development:
Teresa L. Wright, CCRP
• Phone: (305) 279-0015 ext. 4223 / Email: twright@miamiresearch.com]
Douglas Kalman PhD, RD
• Phone 305 666-2368 / Email: dkalman@miamiresearch.com
Karol Keller, DVM
• Phone: (954) 351-8868 / Email: kkeller@miamiresearch.com
Director of Operations: Marysol Cassola
• Phone: (305) 279-0015 ext. 4250 / Email: mcassola@miamiresearch.com