The research proposed is for the establishment of a registry of data that shall be collected and analyzed from existing and on-going registries and clinical trials. The registry shall combine patient level data from high quality registries and clinical trial data sets of drug eluting stents (DESs) and bare metal stents (BMSs). Rates of long term success and of adverse events will be evaluated. Additional data shall be collected and utilized in analysis as participant registries continue to collect and transmit data to the Registry. The Registry shall: 1) provide biostatistical support for protocol development, including power and sample size calculations; 2) monitor collection and analysis of registry data; 3) provide administrative guidance, oversight, and support for the registry as a whole; 4) develop a manual of operations, registry forms and informed consent documents in collaboration with a Steering Committee and the NHLBI; 5) make travel arrangements and reimbursement for registry personnel; 6) coordinate, plan, make arrangements for, and participate in the Steering Committee meetings and its subcommittees; 7) prepare and distribute minutes of meetings; 8) establish and maintain the necessary hardware and software required to process, store and analyze registry data; 9) prepare and distribute periodic technical and statistical reports; 10) review, registry plans, procedures, activities, and data to ensure the scientific validity and clinical relevance of the registry; and 11) provide administrative and logistical support for publication and dissemination of findings. The Registry shall have experience in developing plans for analyzing large numbers of clinical measures from clinical trials and registry data sets. The Registry shall have experience integrating and analyzing data from different clinical trial and registry databases. The Registry shall provide adequate facilities available for receiving, processing, storing, and retrieving medical data efficiently, including the ability to automate the processing of data forms. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) (http://www.ccr.gov). It is anticipated that Registry of Angioplasty Registry Request for Proposals (RFP) will be available fifteen (15) days after the publication of this synopsis. This is a competitive requirement that has been set-aside for small businesses. The RFP will be available in FedBizOpps and electronically via the NHLBI Website. For questions regarding this announcement, please contact Tirene Crowell via telephone at 301-435-0335 or via email @ [email protected].

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