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.

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

8. MRA
Therapeutic Areas
THERAPEUTI
C
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. 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

13. Investigator: Bruce Kohrman, MD Neurology
Department

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

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

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