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TRANSCRIPT
“Making a Difference for the Future”
M I A M I R E S E A R C H A S S O C I A T E S
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.
Overview
Miami Research Associates (MRA) was established in 1996.
MRA is the largest physician-ownedMulti-specialty clinical research center in the United States.
Over 1,000 Phase I-IV clinical trials successfully conducted.
MRA Research Centers
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
Overview > Multi-specialty Therapeutic Divisions:
Dermatology- Dr. Robert Goddard
Gastroenterology- Dr. Harris Goldberg - Dr. Howard Schwartz
Phase I Unit Director- Dr. Patricia Pardo
Nutrition/Endocrinology- Dr. Diane Krieger
Pulmonology- Dr. Jeremy Tabak
Rheumatology- Dr. Jaime Pachón
- Dr. Eric Sheldon
Neuroscience> Psychiatry
- Dr. Americo F. Padilla
> Neuropsychology- Rafael Rivas-Vazquez, Psy.D. - Gustavo J. Rey, PhD
> Neurology- Dr. Bruce Kohrman
Ophthalmology- Dr. Ann Elizabeth Ballen
Pediatrics - Dr. Adriana Castro
Urology - Dr. John Mekras
MORE >
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
Overview > Multi-specialty Therapeutic Divisions:
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
Human Subject Protection
Accredited Since 2010
Our History
1992- Hurricane Andrew
- Dr. Howard Schwartz began conducting H. Pylori studies
1996- Dr. Schwartz
partnered with Dr. Eric Sheldon and Dr. Robert Salzman’s Rheumatology research division to form Miami Research Associates
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
Broward Research Group (BRG) opened its doors under the care of Medical Director Dr. David Seiden,Board Certified in Neurology & Sleep Medicine
Our History > Growth/New Divisions
2001
2005 Opened the In-patient
& Sedation Divisionat South Miami Hospital
Increased our patientrecruitment resourcesto include in-house Multi-Media Radio & TV capabilities
Our History > Growth/New Divisions
Our History > Growth/New Divisions
Miami Research Associates built an 18,000 square feet research facility.2006
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
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
Our History > Growth/New Divisions
Sponsor PartnersSome of our sponsor partners include:
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
30 years or more Linda Camp, MA*
20 years or more Vivian Rosales*
15-20 years Margarita Mederos
10-15 years Mirnaya Alabaci* Isabel Pino, ARNP-BC* Marlene Piloto Linda Nannini, LPN* Teresa L. Wright, CCRP Meredith Arguelles, LPN* Martha I. Quinones
5-10 years Douglas Kalman, PhD* Terry Piedra* Thelma Beltran, LPN* Gisela Cortina Surisaday Mederos, RN* Sharon Oxford, CDT Jack Mesa, MCP Elaine Moncayo Samantha Feldman, RD* Karol Keller, DVM Ricardo Aleman, BA* Jose Garcia, MBA
Our Dedicated Staff
* = denotes CCRC Certification
5-10 years Edith Bethencourt* Olga Gisbert Anita Puras* Melissa Gonzalez* Karin Suarez* Delia Fernandez Marysol Cassola Krizia Vidiella Ann Kramer Karina Arencibia* Beatriz Rivera Alexandra Galvis
Adriana Acosta, ARNP-BC Elsa V. Esquen Karla Pentzke Pilar Hurtado, RMA* Asly Uzcategui Isett Caro* Noris Peraita, RN* Janeen Rosales, BS* Kenia Capdevilla* Frances Beltran Myriam Rosado
Our Dedicated Staff > (continued):
* = denotes CCRC Certification
Many of our staff members continue their education while working at MRA.
Here are some recent graduates …
Our Dedicated Staff > Education
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
Dedicated Phase I Center
We do studies other sites can’t.We do studies other sites can’t.
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
Phase I > Trial Experience
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
As of January 2011, our Phase I Center completed over 80 trials, including:
Phase I > Facility Description
11,000 Square Feet 50 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
Security Cameras throughout the facility Key Card Restricted Access Closed-Circuit TV
Entertainment DVDs Video Games Board Games Flat panel TVs Educational/Art Activities
Phase I > Clinical Capabilities
Equipment:
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
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
Phase I > Special Populations
Elderly Hepatic Renal Psoriasis Type II Diabetes Post-Menopausal Hypertension
Obesity Parkinson’s Depression Pediatric ADHD Arthritis
o Rheumatoido Osteoarthritis
Lupus
MRA Business DevelopmentSite Feasibility
Initial Communication with Sponsor/CRO
Confidentiality Agreements
Synopsis Review
Feasibility Questionnaires
Pre-Study Site Visits
Teresa L. Wright, CCRP
Karol Keller, DVM
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
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
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
Recruitment/Retention
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
Retention
Early patient education Establish good rapport with
subjects Frequent follow-up and
reminder contacts via phone, emails and SMS texting
Quality Assurance
SOP Creation, Revision, and Implementation Sponsor/FDA Audit Preparation Inform Study Coordinators through the “QA Tip of the Week” Standardization Upfront/Backend QA
Linda Camp (Center), along with Ana Soler and Victoria Czenstochouski,are responsible for:
Site TrainingMRA 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
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
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
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
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
Electronic Data CaptureOur research staff EDC systems
training includes
I*NET Trialink Phoenix Data Systems Inform / Phase Forward Flex DMS Oracle RDC Medidata/Rave StudyWorks QDS DEAS
Data Entry usually occurs within 24 hours of seeing the subject
Quality ControlSubject’s source
document is reviewed prior to and during data entry
Data Clarifications are answered within 24 hours of receipt
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
Conclusion
Key Contacts Medical Director: Howard I. Schwartz, MD
• Phone: (305) 598-3125 / Email: [email protected]
Medical Director: Eric A. Sheldon, MD• Phone: (305) 598-3125 / Email: [email protected]
Business Development:• Teresa L. Wright, CCRP
• Phone: (305) 279-0015 ext. 4223 / Email: [email protected]
• Karol Keller, DVM• Phone: (954) 351-8868 / Email: [email protected]
Director of Operations: Marysol Cassola• Phone: (305) 279-0015 ext. 4250 / Email: [email protected]