MIAMI RESEARCH ASSOCIATES      “Making a Difference for the Future”
Mission Statement  To share our clinical research expertise inpartnership with the pharmaceutical industry, in   order to ...
Overview Miami Research Associates (MRA) was  established in 1996. MRA is the largest physician-owned  Multi-specialty c...
MRA Research Centers
MRA Operations   MRA Primary Campus   Phase I Center   Broward Research Group (Sister Site)   Sleep Centers (Broward &...
Overview > Multi-specialty Therapeutic Divisions:   Dermatology                  Neuroscience     -   Dr. Robert Goddard...
Overview > Multi-specialty Therapeutic Divisions:                           Sleep Disorders                            - ...
Human Subject Protection   Association for the Accreditation of    Human Research Protection    Programs (AAHRPP)   MRA ...
Our History1992                      1996  - Hurricane Andrew        - Dr. Schwartz partnered                             ...
Our History > Growth/New Divisions              1998                 Psychiatry Division established                   o ...
Our History > Growth/New Divisions2001  Broward Research Group (BRG) opened its doors  under the care of Medical Director ...
Our History > Growth/New Divisions              2005               Opened the In-patient                & Sedation Divisi...
Our History > Growth/New Divisions2006Miami Research Associates built an 18,000 square feet research facility.       Key ...
Our History > Growth/New Divisions2007   Opened an 11,000 square foot, 50    bed state of the art Phase 1 Unit   Began L...
Sponsor PartnersSome of our sponsor partners include:
Research Staff Overview         MRA is proud of its low employee          turnover rate         Our Senior Research Coor...
Our Dedicated Staff30 years or more                  5-10 years      Linda Camp, MA*                   Douglas Kalman, P...
Our Dedicated Staff > (continued):5-10 years     Edith Bethencourt*      Adriana Acosta, ARNP-BC     Olga Gisbert      ...
Our Dedicated Staff > EducationMany of our staff members continue their educationwhile working at MRA.Here are some recent...
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...
Phase I > Trial ExperienceAs of January 2011, our Phase I Center completed over 80 trials, including:   First-in Man   P...
Phase I > Facility Description   11,000 Square Feet             Security       50 Active Beds                 Cameras ...
Phase I > Clinical CapabilitiesEquipment:                          Emergency Equipment:      Mortara Wireless Telemetry  ...
Phase I > Special Populations   Elderly               Obesity   Hepatic               Parkinson’s   Renal            ...
MRA Business Development                         Site Feasibility                              Initial Communication with...
Protocol DevelopmentUnder Direction of:       Diane R. Krieger, MD       Samantha Feldman, MS, RD, CDE, CCRC       Doug...
Contracts & Regulatory            Rapid turnaround time            Regulatory Document Completion            Central IR...
Marketing/Advertising   In-house advertising agency   Multi-media capabilities       Print       Radio       TV     ...
Recruitment/RetentionRecruitment                            Retention   Advertising in local media,           Early pati...
Quality Assurance                                         Linda Camp                                         (Center), alo...
Site Training     MRA conducts various trainings     throughout the year in order to provide     our staff with the most c...
Pharmacy/Drug Storage       All Study Drug is kept in secure pharmacy           Temperature (24/7, Min and Max Recording...
LaboratoryLaboratory Management   Evaluates protocol to establish laboratory needs   Attends SIV   Coordinates with res...
Safety & Protocol Adherence          Prior to screening the first subject:             Protocol-specific training is held...
Technology     High level of network security     Virtualization- On-site and off-site     2 System-tier for Internet (...
Electronic Data CaptureOur research staff EDC systems      Data Entry usually occurstraining includes                    ...
ConclusionMRA excels at conducting complex clinical trials due to:    Highly-trained clinical staff    Multi-specialty p...
Key Contacts   Medical Director: Howard I. Schwartz, MD     •   Phone: (305) 598-3125 / Email: hschwartz@miamiresearch.co...
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Mra Main Presentation 08 25 11 Ppshow Final Tw

  1. 1. MIAMI RESEARCH ASSOCIATES “Making a Difference for the Future”
  2. 2. Mission Statement To share our clinical research expertise inpartnership with the pharmaceutical industry, in order to discover and develop innovative medicines and other healthcare solutions that enrich people’s lives.
  3. 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. 4. MRA Research Centers
  5. 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. 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. 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. 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. 9. Our History1992 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. 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. 11. Our History > Growth/New Divisions2001 Broward Research Group (BRG) opened its doors under the care of Medical Director Dr. David Seiden, Board Certified in Neurology & Sleep Medicine
  12. 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. 13. Our History > Growth/New Divisions2006Miami 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. 14. Our History > Growth/New Divisions2007 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. 15. Sponsor PartnersSome of our sponsor partners include:
  16. 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. 17. Our Dedicated Staff30 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, CDT10-15 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. 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. 19. Our Dedicated Staff > EducationMany of our staff members continue their educationwhile 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. 20. Dedicated Phase I Center We do studies other sites can’t. We do studies other sites can’t.
  21. 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. 22. Phase I > Trial ExperienceAs 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. 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. 24. Phase I > Clinical CapabilitiesEquipment: 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. 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. 26. MRA Business Development Site Feasibility  Initial Communication with Sponsor/CRO  Confidentiality AgreementsTeresa L. Wright, CCRP  Synopsis Review  Feasibility Questionnaires  Pre-Study Site Visits Karol Keller, DVM
  27. 27. Protocol DevelopmentUnder 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. 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. 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. 30. Recruitment/RetentionRecruitment 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. 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. 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. 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. 34. LaboratoryLaboratory 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. 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
  36. 36. 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
  37. 37. Electronic Data CaptureOur research staff EDC systems  Data Entry usually occurstraining 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
  38. 38. ConclusionMRA 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
  39. 39. 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

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