Approval is Only Chapter I

Expertise in Guiding Late Phase Clinical Cardiology Research

Beyond Registration: The Essential Role of Late Phase Cardiovascular Research

Registration research is required by regulators and deals exclusively with safety and efficacy. Late Phase cardiovascular research is, for the most part, voluntary; sponsors choose to do it to develop information that will allow them to identify competitive advantages, optimize treatment guidelines, and develop rationales that will win over physicians, patients, advocacy groups, insurers and of course Medicare and Medicaid.

In addition, regulators are demanding more information about hidden safety issues that emerge only after repeated real-world product usage by large, diverse populations over long periods of time. That, too, is a critical objective of Late Phase research.

Premier Research can help you decide up front which kind of Late Phase research will give you the information you need most efficiently and cost-effectively.

And then we can help you execute it, from study planning, logistics and recruitment to site management and data processing and evaluation – a critical issue due to the massive volumes of data developed in large-scale Late Phase studies.

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