Miami Research Associates (MRA) is a full-service clinical research organization that conducts approximately 75 clinical trials per year across many therapeutic areas except oncology. In 2013, MRA joined QPS Holdings, a contract research organization. MRA has over 150 employees, including 40 certified research coordinators. It has successfully conducted over 1,500 clinical trials since 1996. MRA operates specialized departments for sleep disorders, gastroenterology, rheumatology, psychiatry, and other areas. It has a dedicated phase 1 center and focuses on recruiting special patient populations. MRA prioritizes quality, compliance, and using various technologies and marketing strategies to support its clinical trials.

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. 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 Ballen
Dr. Juan Aguilar
 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

8. MRA
Therapeutic Areas
THERAPEUTIC
AREAS

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.  Anthrax
 Ebola
 Meningococcal Grp B
 Staph aureus
 Clostridium difficile
 Pandemic (Avian) Flu
 Seasonal Flu
 RSV
 Pneumococcal
 Herpes Zoster (intradermal)
 Influenza H1/H5 (electroporation)
 Tetanus/Diphtheria/Pertussis
 H1N1 (Swine) Flu
 Botulism
 HIV
 Pseudomonas Monoclonal
Antibody
Vaccine
Investigator: Eric Sheldon, MD Department

13. 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: Bruce Kohrman, MD Neurology
Department

15. 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

16. Investigator: Diane R. Krieger, MD
Douglas S. Kalman, PhD, RD, FACN -Director
Samantha Feldman, MS, RD, CCRC- Special Projects
Nutrition
Department
Nutrition/Endocrinology Division
 Pharmaceutical Studies
 OTC
 Medical Nutrition Therapy Products
 Nutritional Product Studies
 Dietary Supplement
 Functional Food
 Raw Material

17. 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

20. Dedicated
Phase I Center
We do studies other sites can’t.

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