Phase iiB-iii clinical trial Feasibility Studies

Identify Challenges. Manage Risk.

Controlling time and cost are top priorities in clinical development. With regulatory authorities requiring more clinical data, increasingly-complex protocols, and the challenges of recruiting patients and qualified investigators, early and careful evaluation of your protocol and recruitment plans can help avoid costly missteps.

PharmaNet/i3's feasibility capabilities can help you identify strategies to mitigate the costs and risks associated with a particular trial. At the protocol level, PharmaNet/i3 will validate whether the protocol has been designed to meet global requirements. Early identification of potential obstacles enables changes to be made before a costly amendment is required. A PharmaNet/i3 feasibility assessment can also help identify the best sites and/or countries in which to place the study, and provide meaningful insight into the potential challenges of multi-cultural recruitment, the impact of competitive trials, patient access and retention, medical infrastructure, staff experience and expertise, and regulatory timelines. Best of all, PharmaNet/i3 makes recommendations to mitigate the related challenges identified.

Our significant feasibility experience across a variety of therapeutic areas allows us to provide quality data and global insight that is directly supported by experienced CRAs around the world who survey investigators in the local language. Our Medical and Scientific Affairs team also provides input into the feasibility questionnaire, reviewing potential medical concerns from investigators, and commenting on the overall feasibility of the protocol.

PharmaNet/i3 maintains exclusive access to United Health Group's U.S.-based medical claim data. In addition, PharmaNet/i3 has access to 120 million patients and their related prescription claims data through an inVentiv Health affiliate, Adheris. Our feasibility experts not only mine the data, but know how to make it work for our clients. use of the data can provide insight to niche populations, patient demographics, longitudinal data, and treating physician pattern that can guide site selection, referring physician programs and help target patient recruitment strategies.

With an expert team coupled with innovative and unique tools to guide patient access decisions, let PharmaNet/i3's feasibility services work for you.