Clinical Research The HRFUP experience has included epidemiologic, pharmacologic, and medical device research studies. The HRFUP research interests include but are not limited to cardiovascular physiology, cardiac arrhythmias, sudden death, myocardial infarction, posthospital phase of myocardial infarction, heart failure, ventricular repolarization, thrombogenic factors and pharmacoeconomics. The HRFUP has direct contact with a diverse group of investigators world-wide. The HRFUP also actively collaborates with various departments at University of Rochester (Neurology, Pulmonology, Environmental Diseases, Pediatrics, Community and Preventive Medicine) on studies involving cardiovascular research in relationship to neurologic disorders, asthma and COPD disorders, environmental exposure to air pollution and mercury. The Heart Research Follow-up Program (HRFUP) has been involved in the design, conduct, and analysis of local and world-wide, multicenter, clinical research studies from 10-3500 subjects since 1970. The studies have ranged from small or large observational studies to Phase I –IV clinical trials using specific drug or device intervention. These studies use the latest basic science, bioengineering, genetic, biostatistical, physiological, and clinical approaches to optimize the acquisition of new knowledge in order to improve the diagnostic and therapeutic foundation of clinical medicine. The advancement of medical science requires basic investigation into the mechanisms of disease, improvement in clinical diagnosis and risk stratification, and development and testing of new therapies to substantiate their safety and efficacy. The goal of each research project is to improve the human medical condition. In all of the studies, the HRFUP has consistently met specified enrollment numbers by recruiting strong capable enrolling center investigators, effectively coordinated multicenter activities including maintenance of regulatory standards, maintained proper quality control of large amounts of data, used sophisticated multivariate analytic methods, published definitive reports in major journals in a timely manner following completion of each study, and assisted with data submissions as requested by the study sponsors and the FDA. One hallmark of the HRFUP is to statistically design cost-effective studies using sequential analysis techniques to potentially allow for early study termination. Another hallmark of the HRFUP is to maintain strict rules of data safety/monitoring to insure investigator and sponsor independence and data integrity to facilitate rapid product approval from the FDA. The HRFUP has been successfully audited by external independent companies as well as the FDA. The HRFUP has an outstanding reputation for scientific excellence. Our academic-based, full-facility research center has access to a vast array of University based services. The HRFUP provides the highest professional standards to meet the all aspects of the diverse management requirements of clinical research studies in a cost effective, timely manner. Data Coordination Center Services Summary of Services Protocol Review by Experienced Clinical Trials Faculty Study Administration Development and Regulatory Document Tracking Study Operations Design and Implementation Case Report Form (CRF) Development and Management Provide FDA-Compliant Host Server Environment Development and Implementation of FDA-Compliant Electronic Data Capture System Using Real-Time Web-Enabled Portal for Single or Multicenter Studies, including 24/7 electronic subject enrollment and randomization service to enrolling centers Creation and Maintenance of Compliance Documentation , including departmental policies, procedures, and work instructions Development of requirements specifications, testing, and validation of supporting end-user computer applications Data Quality Control Integration of Data Coding Dictionaries Study Reporting including Data Summaries and Event Reporting to Enrolling Centers, Data Safety and Monitoring Boards, Research Subject Review Boards, Sponsors Automated Study Invoicing Core Laboratory and Drug Distribution Electronic Data Integration Study Training Technical and Study Support Full Data Backup Capability Coordination of study closeout Database Lock and Data Transfer (Interim and Final Clinical Research Experience The HRFUP experience has included epidemiologic, pharmacologic, and medical device research studies. The HRFUP research interests include but are not limited to cardiovascular physiology, cardiac arrhythmias, sudden death, myocardial infarction, posthospital phase of myocardial infarction, heart failure, ventricular repolarization, thrombogenic factors and pharmacoeconomics. The HRFUP has direct contact with a diverse group of investigators and core laboratories world-wide, many of whom we have worked with since the inception of the HRFUP. The HRFUP also actively collaborates with various departments at University of Rochester (Neurology, Pulmonology, Environmental Diseases, Pediatrics, Community and Preventive Medicine) on research studies related to neurologic disorders, asthma and COPD disorders, environmental exposure to air pollution and mercury. The HRFUP collaborates with other services within the University such as biostatistics, pharmacy services, and various core laboratories for analysis of samples and testing results. Facility Description The HRFUP has a staff of highly trained professionals who have extensive experience in all aspects of FDA compliance, data management, trial management and coordination of corporate and government-funded research studies similar to a Contract Research Organization (CRO). The HRFUP in-house quality assurance and compliance management allows the conduct of studies that exceeds FDA standards. The HRFUP has direct access to world-class biostatisticians with vast experience in project design and analysis. The HRFUP conducted one of the first device trials utilizing sequential analysis that saved considerable money for the sponsor through early termination and FDA submission. FDA submission and labeling approval was also accelerated, because the data for this project was delivered directly by the HRFUP. The HRFUP has several in-house computer servers using the latest clinical trial software technologies to accommodate all aspects of data management. The HRFUP has access to leading core laboratories such as hematology, lipidemiology, or angiography to analyze any ancillary tests that may be required. The HRFUP in conjunction with the University can also provide support for all contractual and regulatory needs including rapid IRB approval. The HRFUP has directed the following studies (* = ongoing): Catecholamines and Cardiovascular Dysfunction (NIH) Follow-up Study of Acute Coronary Heart Attacks (NIH) Multicenter Postcoronary Risk Stratification Program (NIH) Long QT Syndrome: Population, Genetic and Cardiac Studies (NIH) Digitalis Withdrawal Trial (Burroughs Wellcome) Evaluation of Electric Fields on Pacemakers (Electric Power Research Institute) Flecainide Postinfarction Trial (Riker Laboratories) Multicenter Diltiazem Postinfarction Trial (Marion Laboratories) Nadolol Repolarization Study (Princeton Pharmaceuticals) Multicenter Study of Silent Myocardial Ischemia (NIH) Coumadin Aspirin Reinfarction Study (DuPont Merck) Long QT Syndrome: Genetic Studies (NIH) Multicenter Automatic Defibrillator Implantation Trial (CPI/Guidant) Thrombogenic Factors and Recurrent Coronary Events (NIH) Repolarization Analysis in Diphenhydramine Overdose Patients (Warner Lambert) Intercity Digital Electrocardiology Alliance (Burdick) Repolarization Analysis in Patients Treated with Mibefradil (Hoffman LaRoche) Multicenter Automatic Defibrillator Implantation Trial II (Guidant/Boston Scientific) Multicenter Automatic Defibrillator Implantation Trial II Risk Stratification Study (NIH) Long QT Syndrome Implantable Defibrillator Registry (Medtronic, Boston Scientific)* Arrhythmogenic Right Ventricular Depolarization Study (NIH) Study of Ventricular Repolarization in Long QT Syndrome (NIH) Multicenter Automatic Defibrillator Implantation Trial Using Cardiac Resynchronization Therapy (Guidant/Boston Scientific) Multicenter Automatic Defibrillator Implantation Trial Using Cardiac Resynchronization Therapy Registry (Guidant/Boston Scientific) Multicenter Automatic Defibrillator Implantation Trial Reduce Inappropriate Therapy Study (Guidant/Boston Scientific) Study of the Wearable Defibrillator: In Advanced Heart Failure Patients (LifeCor)* RAID - Ranolazine ICD Trial (NIH)* Interest of IKr-related Abnormalities of ECGs to Improve Drug-safety Evaluation (NIH) Ranolazine in LQT3 Patients (Gilead Sciences)* Genetics, Mechanisms and Clinical Phenotypes of Arrhythmogenic Cardiomyopathy (NIH)* QT RR Dynamic Coupling in Patients with the Long QT Syndrome (NIH)* LQT3 Registry (Gilead Sciences)* Multicenter Automatic Defibrillator Implantation Trial: Chemotherapy-Induced Cardiomyopathy (MADIT-CHIC)* Risk-Stratification of Patients with the Long QT Syndrome (LQTS) based on Holter Recordings (NIH)* A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects with Implantable Cardioverter-Defibrillator (ICD) or Cardiac ResynchronizationTherapy-Defibrillator (CRT-D) (Gilead Sciences)* A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects with Paroxysmal Atrial Fibrillation (Gilead Sciences)* An Open-label Study to Evaluate the Effect of Single Dose GS-6615 on QT, Safety and Tolerability in Subjects with Long QT-3 Syndrome (Gilead Sciences). Contact Information Contact Mary Brown at (585) 275-5391 or email@example.com if you would like to discuss how the services offered by the Coordination and Data Center could provide resources to assist you with your research study needs.