The HRFUP has a staff of highly trained professionals who have extensive experience in all aspects of management and coordination of research studies. The HRFUP in-house quality assurance and 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 an in-house mainframe computer to accommodate all aspects of data management. The HRFUP has access to leading core laboratories such as hematology, lipidemeology, 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 also been involved in electrocardiology research for over 20 years. The main focus of this research is on ventricular arrhythmias and ventricular repolarization analyses. The HRFUP ECG core laboratory is prepared to conduct analysis of all types of ECG recordings including standard 12-lead ECG, signal-averaged ECG (SAECG), digital high-resolution ECG, and analog or digital long-term 24-hour Holter recordings. The HRFUP is equipped to scan and digitize a paper copy of an ECG to accomplish a more sophisticated computer analysis.
The HRFUP is fully equipped and prepared to conduct computer analyses of various high-resolution and long-term digital ECG recordings. The HRFUP has developed computer programs that interpret various aspects of ECG changes including, but not limited to, repolarization analysis in standard and long-term recordings, atrial and ventricular arrhythmia analyses, ST-T segment evaluation, P-wave and QRS signal-averaging, and heart rate variability analyses. The HRFUP ECG analytic facilities are merged with a central computer clinical data management system that has been developed and validated over a period of 20 years.