The changing regulatory climate is making it necessary to collect better safety data from larger numbers of patients in real-world settings, to answer increasingly detailed questions about drug risks and clinical evidence that new therapies provide better outcomes or greater value than existing standards of care.
To meet those growing data requirements, biopharmaceutical companies need a wider range of product safety, effectiveness and optimal use information that is not available from most Phase III trials.
Late phase research requires a specialized approach, including: strategic understanding of the study objectives and design options to achieve goals; knowledge of the complex nature of the results generated and how to maximize the data analysis during and after the trial; in-depth understanding of the operational issues involved in managing late phase studies; expertise in the disease or therapeutic area and ultimately global capabilities coupled with local market expertise.
Given the size and scope of most late phase studies, greater efficiency in logistics, access to appropriate patients and investigators and information processing are absolutely essential to control costs and handle the huge volume of data.
Pierrel Research delivers high level expertise in drug use and treatment outcomes in real-world clinical practice through our Late Phase Solutions from Phase IIIb to post-approval registries and observational studies.
Equally important is the use of HyperSuite®, our comprehensive Electronic Data Capture Solution, to ensure efficient and cost effective management of these trials.