1. MIAMI RESEARCH ASSOCIATES
“Making a Difference for the Future”

2. Mission Statement
To share our clinical research expertise in
partnership with the pharmaceutical industry, in
order to discover and develop innovative
medicines and other healthcare solutions that
enrich people’s lives.

3. Overview
 Miami Research Associates (MRA) was
established in 1996.
 MRA is the largest physician-owned
Multi-specialty clinical research center in
the United States.
 Over 1,000 Phase I-IV clinical trials
successfully conducted.

4. MRA Research Centers

5. MRA Operations
 MRA Primary Campus
 Phase I Center
 Broward Research Group (Sister Site)
 Sleep Centers (Broward & Miami-Dade)
 International Operations (Dominican Republic)
 Patient Recruitment Advertising Agency

6. Overview > Multi-specialty Therapeutic Divisions:
 Dermatology  Neuroscience
- Dr. Robert Goddard > Psychiatry
 Gastroenterology - Dr. Americo F. Padilla
- Dr. Harris Goldberg > Neuropsychology
- Dr. Howard Schwartz - Rafael Rivas-Vazquez, Psy.D.
- Gustavo J. Rey, PhD
 Phase I Unit Director
- Dr. Patricia Pardo > Neurology
- Dr. Bruce Kohrman
 Nutrition/Endocrinology
- Dr. Diane Krieger
 Ophthalmology
- Dr. Ann Elizabeth Ballen
 Pulmonology
 Pediatrics
- Dr. Jeremy Tabak - Dr. Adriana Castro
 Rheumatology  Urology
- Dr. Jaime Pachón - Dr. John Mekras
- Dr. Eric Sheldon
MORE >

7. Overview > Multi-specialty Therapeutic Divisions:
 Sleep Disorders
- Dr. Howard Schwartz
- Dr. Timothy Grant
 Vaccines
- Dr. Eric Sheldon
 Cardiology
- Dr. Harry Aldrich
- Dr. Abbe Rosenbaum
 Women’s Health
- Dr. Robert Feldman
 Anesthesiology
- Dr. Michael Meister
- Dr. Guillermo Pol

8. Human Subject Protection
 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

9. Our History
1992 1996
- Hurricane Andrew - Dr. Schwartz partnered
with Dr. Eric Sheldon and
Dr. Robert Salzman’s
Rheumatology research
division to form Miami
Research Associates
- Dr. Howard Schwartz
began conducting H.
Pylori studies

10. Our History > Growth/New Divisions
1998
 Psychiatry Division established
o Pediatric & Adult Psychiatry
1999
 Established the Women’s Health Division
2000
 Sleep Medicine Division
 Nutrition/Endocrinology Division

11. Our History > Growth/New Divisions
2001
Broward Research Group (BRG) opened its doors
under the care of Medical Director Dr. David Seiden,
Board Certified in Neurology & Sleep Medicine

12. Our History > Growth/New Divisions
2005
 Opened the In-patient
& Sedation Division
at South Miami Hospital
 Increased our patient
recruitment resources
to include in-house Multi-Media
Radio & TV capabilities

13. Our History > Growth/New Divisions
2006
Miami Research Associates built an 18,000 square feet research facility.
 Key Advantages:
 All Investigators are on-site, which makes
them easily accessible
 South Miami Hospital is located on the
same city block
 Improved flexible staff resourcing between
divisions
 On-site Equipment Includes:
 Endoscopy Suite
 Clinical RSVP (Digital Subject Validation)
 DEXA Scan
 Echocardiogram
 ECGs
 Digital X-Ray
 Driving Simulator

14. Our History > Growth/New Divisions
2007
 Opened an 11,000 square foot, 50
bed state of the art Phase 1 Unit
 Began Latin American Research, in
Santo Domingo, D.R.
 Expanded our Sleep Center capabilities
to 12 bedroom suites
 Added Text Marketing capabilities to our
in-house patient recruitment multi-media
center

15. Sponsor Partners
Some of our sponsor partners include:

16. Research Staff Overview
 MRA is proud of its 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

17. Our Dedicated Staff
30 years or more 5-10 years
 Linda Camp, MA*  Douglas Kalman, PhD*
20 years or more  Terry Piedra*
 Vivian Rosales*  Thelma Beltran, LPN*
15-20 years  Gisela Cortina
 Margarita Mederos  Surisaday Mederos, RN*
 Sharon Oxford, CDT
10-15 years  Jack Mesa, MCP
 Mirnaya Alabaci*  Elaine Moncayo
 Isabel Pino, ARNP-BC*  Samantha Feldman, RD*
 Marlene Piloto  Karol Keller, DVM
 Linda Nannini, LPN*  Ricardo Aleman, BA*
 Teresa L. Wright, CCRP  Jose Garcia, MBA
 Meredith Arguelles, LPN*
 Martha I. Quinones * = denotes CCRC Certification

18. Our Dedicated Staff > (continued):
5-10 years
 Edith Bethencourt*  Adriana Acosta, ARNP-BC
 Olga Gisbert  Elsa V. Esquen
 Anita Puras*  Karla Pentzke
 Melissa Gonzalez*  Pilar Hurtado, RMA*
 Karin Suarez*  Asly Uzcategui
 Isett Caro*
 Delia Fernandez
 Noris Peraita, RN*
 Marysol Cassola
 Janeen Rosales, BS*
 Krizia Vidiella
 Kenia Capdevilla*
 Ann Kramer  Frances Beltran
 Karina Arencibia*  Myriam Rosado
 Beatriz Rivera
* = denotes CCRC Certification
 Alexandra Galvis

19. Our Dedicated Staff > Education
Many of our staff members continue their education
while working at MRA.
Here are some recent graduates …
 Ivette Hernandez, RN
 Naime Reyno-Ramos, RN
 Yelenia Reyno, RN
 Noris Peraita, RN
 Surisaday Mederos, RN
 Ricardo Aleman, BA
 Jose Garcia, MBA
 Poliana Ayala, completing RN degree
 Chelsea Cabrera, completing RN degree
 George Sanchez, MD

20. Dedicated Phase I Center
We do studies other sites can’t.
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 January 2011, our Phase I Center completed over 80 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. Phase I > Facility Description
 11,000 Square Feet  Security
 50 Active Beds  Cameras throughout the facility
 Central Nursing Station  Key Card Restricted Access
 Closed-Circuit TV
 Multiple dorms configured
for privacy, cohort mgmt.  Entertainment
 DVDs
 Internet access via
 Video Games
desktops & Wi-Fi
 Board Games
 Three activity areas  Flat panel TVs
 24-hour lab turnaround  Educational/Art Activities
 Customized meals by
registered dietitians
 Across from South Miami
Hospital

24. Phase I > Clinical Capabilities
Equipment: Emergency Equipment:
 Mortara Wireless Telemetry  Emergency Room located less
 EEG than 100 yards from unit
 ECG  Crash Cart
 Refrigerated Centrifuges  Emergency Medications
 Echocardiogram  2 Defibrillators
 Endoscopy  Oxygen Tank
 PSG Recording  Pull Cord Emergency Service
 DEXA Scanner installed in bathrooms
 Digital X-Ray
 -70°C Freezers
 Spirometry
 Compounding Scale
 Biosafety Cabinet Level 2 Certified Hood
 Slit Lamp

25. Phase I > Special Populations
 Elderly  Obesity
 Hepatic  Parkinson’s
 Renal  Depression
 Psoriasis  Pediatric ADHD
 Type II Diabetes  Arthritis
 Post-Menopausal o Rheumatoid
o Osteoarthritis
 Hypertension
 Lupus

26. MRA Business Development
Site Feasibility
 Initial Communication with
Sponsor/CRO
 Confidentiality Agreements
Teresa L. Wright, CCRP
 Synopsis Review
 Feasibility Questionnaires
 Pre-Study Site Visits
Karol Keller, DVM

27. Protocol Development
Under Direction of:
 Diane R. Krieger, MD
 Samantha Feldman, MS, RD, CDE, CCRC
 Doug Kalman, PhD, RD, CCRC, FACN
 Protocol Design
 Protocol Monitoring
 Report Writing
 Statistical Analysis
 Meeting Presentations

28. Contracts & Regulatory
 Rapid turnaround time
 Regulatory Document Completion
 Central IRB Submissions
 Interfaced with Marketing & Advertising
Division for in-house ad creations,
expediting the approval process for
rapid advertising campaign executions

29. Marketing/Advertising
 In-house advertising agency
 Multi-media capabilities
 Print
 Radio
 TV
 Internet (Web Portals/Email Marketing)
 Social Media (i.e. Facebook, Twitter, YouTube)
 SMS (Text Messaging)
 News Releases
 Conferences/Special Events
 Media Buying Power
 Public Relations
 Campaign Response Analytics

30. Recruitment/Retention
Recruitment Retention
 Advertising in local media,  Early patient education
internet and conventional  Establish good rapport with
mediums subjects
 Dedicated Call Center with state  Frequent follow-up and
of the art technology and reminder contacts via phone,
experienced staff emails and SMS texting
 Guerrilla Marketing
 HIPAA Compliant Database of
over 30,000 Willing Subjects

31. Quality Assurance
Linda Camp
(Center), along with Ana
Soler and Victoria
Czenstochouski,
are responsible for:
 SOP Creation, Revision, and Implementation
 Sponsor/FDA Audit Preparation
 Inform Study Coordinators through the “QA Tip of the Week”
 Standardization
 Upfront/Backend QA

32. Site Training
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

33. Pharmacy/Drug Storage
 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
 Backup-Generator in case of power failure

34. Laboratory
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

35. Safety & Protocol Adherence
Prior to screening the first subject:
 Protocol-specific training is held
with PI, Sub-Is, study coordinator
and research staff
 Research staff must complete
study review sheet

37. 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

38. Electronic Data Capture
Our research staff EDC systems  Data Entry usually occurs
training includes within 24 hours of seeing
the subject
 I*NET
 Trialink  Quality Control
 Phoenix Data Systems
 Subject’s source
 Inform / Phase Forward document is reviewed
 Flex DMS prior to and during data
 Oracle RDC entry
 Medidata/Rave  Data Clarifications are
 StudyWorks answered within 24
 QDS DEAS hours of receipt

39. Conclusion
MRA excels at conducting complex clinical trials due to:
 Highly-trained clinical staff
 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

40. Key Contacts
 Medical Director: Howard I. Schwartz, MD
• 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
• 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