Case Study

Evidence Generation Strategic Partnership For Heart Failure Studies

Patient Recruitment

UBC was selected by a major pharmaceutical company to manage a portfolio of 5 studies of patients with heart failure to generate evidence in support of a new product launch. The portfolio of studies was designed to provide insights into disease progression and treatment patterns in a real word setting as well as to assess potential novel efficacy domains that warranted deeper investigation following the pivotal studies supporting product approval. The evidence was important to support publications and potential changes to treatment guidelines and label.

The portfolio included an observational study and 4 interventional studies involving over 500 investigator sites and more than 7,000 patients. The scope and breadth of the portfolio involved diverse study designs and objectives, a range of healthcare setting types, innovative patient-generated data collection approaches, including wearable technology, biomarkers, and novel cardiac function assessment technology. A robust portfolio project plan and partnership charter were developed to drive successful execution of each project timeline within a landscape of overlapping study start-up and deliverable schedules.

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