Clinical Research Partnership In parallel with the impending commencement of HeartWare’s US Bridge-to-Transplant clinical trial, HeartWare is pleased to announce that it has entered into a multi-year partnership with PharmalinkFHI (“Pharmalink”) as the Company’s Clinical Research Organization (“CRO”). Pharmalink is one of the pre-eminent CROs in North America with significant experience and expertise in the management of clinical trials. Importantly, Pharmalink is well-credentialed in the areas of electronic or online data capture (“EDC”), database and data management, statistical support, clinical report production and routine clinical site monitoring. Pharmalink was the first full service CRO to have integrated clinical and technical expertise into the management of clinical trials which allows near real-time access to clinical trial data. HeartWare believes that the use of tools such as EDC will provide more efficient, user-friendly and expedited assimilation of our patient data during our US clinical trials. Partnering with Pharmalink enables HeartWare to focus its internal clinical resources in the areas that are most specialized and will likely have the biggest impact on the outcome of the trial such as procedural training, project management, safety and medical affairs.
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