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“Medical Breakthroughs for Tomorrow”. Our Vision Through our highly specialized Phase I facility, MRA Clinical Research provides the pharmaceutical industry.

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Presentation on theme: "“Medical Breakthroughs for Tomorrow”. Our Vision Through our highly specialized Phase I facility, MRA Clinical Research provides the pharmaceutical industry."— Presentation transcript:

1 “Medical Breakthroughs for Tomorrow”

2 Our Vision Through our highly specialized Phase I facility, MRA Clinical Research provides the pharmaceutical industry with precise clinical trial assessments and quality data in the early phase development arena.

3 Overview Neuroscience  Dr. Bruce Kohrman  Dr. Timothy Grant Psychiatry  Dr. Americo F. Padilla  Dr. Rafael Rivas-Vazquez  Dr. Gustavo J. Rey Sleep Disorders  Dr. Timothy Grant  Dr. Howard Schwartz Pediatric  Dr. Americo F. Padilla  Dr. Adriana M. Castro Vaccines  Dr. Eric Sheldon Women’s Health  Dr. Robert Feldman Multi-specialty Phase I site conducting clinical trials in special populations and healthy volunteers Medical Director: Dr. Patricia Pardo Dermatology  Dr. Robert Goddard Gastroenterology  Dr. Howard Schwartz  Dr. Harris Goldberg Nutrition/Endocrinology  Dr. Diane Krieger Rheumatology  Dr. Eric Sheldon  Dr. Jaime Pachon  Dr. Margarita Garces

4 Our Phase I Unit uniquely:  Provides high-level medical oversight of special populations and healthy volunteers  Exceeds at executing complex, highly-detailed clinical trials

5 Phase I Facility Description 11,000 Square Feet 50 beds Central Nursing Stations Multiple units configured for gender privacy Multiple activity areas Facility layout allows for isolation of different populations, if needed 24-hour lab turnaround Customized meals by registered dietitians Less than ¼ mile from nearest hospital, South Miami Hospital Security  Cameras throughout the facility  Restricted Access via key cards Closed-Circuit Flat Panel TVs Entertainment Internet access via desktops & Wi-Fi

6 Clinical Capabilities Equipment:  Multiple Freezers (-70°C & -20°C)  ECG  EEG  Refrigerated Centrifuges  Cardiac Monitoring  Echocardiography  Endoscopy  DEXA Scanner  Digital X-Ray  Polysomnography (PSG)  Spirometry  Compounding Scale  Biosafety Level 2 Hood Emergency Equipment:  Fully Equipped Crash Cart  Intubation Capababilites on-site  2 Defibrillators  Oxygen Tank  Pull Cord Emergency Service installed in bathrooms  Emergency Room located less than 100 yards from unit

7 Phase I Unit Director Dr. Patricia Pardo is Board Certified in Internal Medicine and an APPI Certified Physician Investigator Completed her training at UM/Jackson Memorial Hospital Former faculty member at University of Miami’s School of Medicine Has participated in the conduct of over 100 clinical trials

8 Director of Operations Ms. Janeen Rosales, BS, CCRC has 10 years experience in the Phase I-IV clinical research arena Previous experience in Project Management and Business Development

9 Research Staff Between MRA and our Phase I unit, we have over 60 experienced study coordinators  38 are ACRP Certified Our study coordinators are:  CITI Certified  NIH Certified  BLS Certified In addition, 4 Project Managers are responsible for overseeing the study and being the primary point of contact for sponsors.  Project Managers are ACRP Certified

10 30 years or more  Linda Camp, MA* 20-30 years  Vivian Rosales* 15-20 years  Maria Heimer*  Margarita Mederos 10-15 years  Mirnaya Alabaci*  Isabel Pino, ARNP-BC*  Marlene Piloto  Linda Nannini, LPN*  Teresa L. Wright, CCRP 5-10 years:  Ilka Morales*  Sharon Oxford, CDT  Meredith Arguelles, LPN*  Terry Piedra*  Surisaday Mederos, MA*  Thelma Beltran, LPN*  Noris Peraita*  Gisela Cortina  Edith Bethencourt*  Elsa V. Esquen  Maria Gomez Our Dedicated Staff * = denotes CCRC Certification

11 5-10 years (continued):  Janeen Rosales, BS*  Douglas Kalman, PhD, RD*  Jack Mesa, MCP  Elaine Martino  Ricardo Aleman, BA*  Martha Quinones  Jose Garcia, BHSA  Maura Quinones  Samantha Feldman, MS, RD, CDE*  Krizia Vidiella  Ann Kramer  Alexandra Galvis  Anita Puras*  Karin Miranda*  Melissa Gonzalez *  Marysol Cassola  Lori Feldman, RD*  Beatriz Rivera * = denotes CCRC Certification

12 In addition, many of our staff have gone on to pursue health-care related degrees, internships, and residencies:  George Sanchez, MD  Ivette Hernandez, RN  Naime Reyno-Ramos, RN  Yelenia Reyno, RN  Noris Peraita, RN  Surisaday Mederos, completing RN degree  Poliana Ayala, completing RN degree  Melissa DeCastro, MS in Speech Pathology  Rodrigo Velasco, completing MD degree  Kristin Irmiter, completing MD degree  Christina De La Vega, completing MD degree

13 Client Relations Over the years, we have established strong business relationships with various pharmaceutical companies, such as:  Amgen  Eli Lilly & Co.  Merck  Novartis  Pfizer  Roche  Shire  Wyeth

14 Special Populations Arthritis  Osteoarthritis  Rheumatoid ADHD  Adult  Pediatric Depression Diabetes  Type II Elderly Healthy Volunteers Hepatic Hypertension Lupus Obesity Parkinson’s Pediatrics Post-Menopausal Psoriasis Renal

15 Subject Safety Step-Wise Systematic Training ACLS Certified Staff must be present at all times Protocol-Specific Training prior to study start Specialty-tailored physician coverage Less than 1500 hundred feet to nearest ER

16 Phase I Experience Food Interaction Pharmacokinetics Dose Ranging Drug-to-Drug Interaction Jet Lag Polysomnography Cardiac Safety Narcotic Safety Endoscopic Safety Bioavailability/ Bioequivalency

17 Phase I Experience Have conducted over 40 studies in various therapeutic areas, in which we achieved the following:  Consistently met enrollment goals  Excellent subject retention (over 90%)  Frequent requests for additional cohorts

18 Recent Phase I Trials Pediatrics:  Open-Label, Dose-escalating safety, tolerability, Pharmacokinetics and cardiovascular safety study including Holter Monitoring and Serial Orthostatic Values in adolescents with ADHD  Open-Label, Randomized, Single and Multiple Dosing PK study in children and adolescents with ADHD

19 Biologics:  Single-Ascending Dose study of the safety, tolerability, PK and PD administered to subjects with Rheumatoid Arthritis  Single-Ascending Dose study of the safety, tolerability, PK, and PD administered to subjects with Lupus  Multiple-Ascending Dose 9-month study of the safety, tolerability, PK and PD of IP following IV infusion in patients with Allergic Rhinitis  Multiple-Ascending Dose study of the safety, tolerability, PK, PD and efficacy of the IP administered Subcutaneously or Intravenously to Subjects With Psoriasis  Multiple-Ascending Dose study safety and tolerability in subjects with Psoriasis Vulgaris Recent Phase I Trials cont’d

20 Hepatic:  Single Dose Study to evaluate the PK, safety, and tolerability of IP in Subjects with Hepatic Impairment and Normal Hepatic Function Healthy Volunteers:  Single Dose study of the safety, tolerability, PK, and PD of IP in Healthy Subjects  Multiple-Dose Study to evaluate the safety, tolerability, PK, and PD of IP in Healthy Subjects Recent Phase I Trials cont’d

21 Neurology:  Dose-Ranging study to assess safety, efficacy, tolerability, and Pharmacokinetics in subjects with Parkinson’s Disease Vaccines:  Have enrolled over 1,100 subjects since 2008  Conducted trials involving: Seasonal Influenza H5N1 Influenza (Avian Influenza) H1N1 Influenza (Swine Influenza) Typhoid Fever Japanese Encephalitis Smallpox West Nile Virus Meningitis Plague Recent Phase I Trials cont’d

22 Consumer Packaged Goods / OTC Switch Experience Over the past 20 years, MRA Investigators have conducted clinical trials in the later stage and post- market arenas, including consumer packaged goods such as:  OTC Migraine  OTC Pain  Smoking Cessation Patches  Sleep Aids  Allergy Preparations  Laxatives  OTC Heartburn

23 Regulatory Regulatory Document Package Review Finance/Marketing Coordination IBC Submissions IRB Submissions  Central IRB  Local IRB Turnaround within 3-5 business days

24 Contracts/Budgets Process Finance Director reviews contract & budget with CEO Budget Negotiation Budget Approval Contract Execution Patient Stipend to Regulatory and Marketing Departments Turnaround within 5 business days

25 Marketing/Advertising Create Site-Specific Advertisements  Print  Radio  Television  Internet In-house radio & video production Guerrilla Marketing  Social Networking Media Buys Response Analysis

26 Recruitment Potential Subjects are recruited through:  Advertising in local media and Internet  Call Center  Guerrilla Marketing  Database of over 30,000 Potential Subjects Security: Password Protection & Encryption

27 Retention Careful pre-screening, early subject education Establish good rapport with subjects Follow-Up Phone Contacts to see how subject is doing and remind them of next visit

28 Upfront Quality Assurance Standardized process that begins upon initial receipt of the protocol Goal is to ensure excellent quality and establish a cohesive process that integrates all departments All study team members are required to participate


30 Laboratory With over 20 years Phase I experience, the Laboratory Manager, Ms. Neiner Enriquez, is responsible for:  Evaluating protocol to establish laboratory needs upon initial receipt  Attending SIV  Coordinating with resource manager to generate calendar of events  Preparing pertinent logs & requisition forms  Preparing laboratory kits needed throughout the study  Shipping & Packaging specimens  Sample retention

31 Pharmacy & IP Storage Security Measures Registered Pharmacists Compounding Pharmacists Biosafety Certified Hood Randomization  Dedicated Fax line IV Infusions Sample Retention TempGuards

32 Quality Assurance SOPs Policies & Procedures Sponsor/FDA Audit Preparation Standardization Real-time QA Upfront/Backend QA Site Training

33 In an effort to have the most current knowledge available to our research staff, many forms of training are held each year: - GCP training - Training Sessions for ACRP Certification Exam - Research Assistant Training for new employees - HIPAA Training - Investigator’s Lunch and Learn Series

34 Electronic Data Capture Our staff is trained in Multiple EDC systems 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

35 Conclusion Our ability to excel in conducting complex clinical trials is due to our: - Highly-trained clinical staff - Multi-specialty physicians on-site and on-call - High Investigator Involvement - Access to a diverse patient population - Outstanding recruitment/retention capability

36 Key Medical Contacts Medical Director: Howard I. Schwartz, MD  Phone: (305) 598-3125  Email: Medical Director: Eric A. Sheldon, MD  Phone: (305) 598-3125  Email: Phase I Unit Director: Patricia Pardo, MD  Phone: (305) 722-0970  Email: Director of Operations: Janeen Rosales, BS, CCRC  Phone: (305) 403-3860 ext. 4102  Email:

37 Key Contacts Business Development, Phase I:  Director: Douglas Kalman, PhD, RD Phone: (305) 666-2368 Email:  Mark Morrison Phone: (919) 787-9528 Email: Business Development, Phase I-IV:  Director: Teresa L. Wright, CCRP Phone: (305) 279-0015 ext. 4223 Email:

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