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30 Aug 2016

Sponsors and CROs agree that integrating statistical modeling and knowledge of past performance into feasibility analyses improves accuracy of results

Informing the pharmaceutical drug development, manufacturing and commercialization industry.

A new report, Best Practices in Study Feasibility, from Industry Standard Research (ISR) reveals insights into how to successfully navigate many of the challenges - medical, clinical, logistical and regulatory - associated with establishing the feasibility of a clinical trial. A key area of interest for readers of the report will be the "Top Techniques and Innovations" for conducting feasibility analyses, where both sponsors and CROs report that the integration of statistical modeling and past performance into feasibility analyses is the number one technique positively affeccting the industry right now.

"ISR surveyed stakeholders from sponsors, CROs and sites to gain insight into feasibility analyses, and with the degree of differences between these groups on objectives and approaches for conducting a feasibility analysis, it is somewhat surprising to see the same concept mentioned as a top technique or innovation from both sponsors and CROs," explained Kate Hammeke, Vice President of Market Research at ISR.

In addition to findings on the top techniques and innovations used when conducting a feasibility analysis, respondents also shared their awareness of feasibility analysis service providers and frequency of use, the percentage of trials that require a feasibility analysis, whether the analysis is conducted in-house or outsourced, the data sources utilized and a ranking of which data sources contribute to the accuracy of the estimate. The report includes key statistics on the characteristics that comprise a predictive feasibility estimate, impressions on the industry's approach to feasibility analysis and the use of SOPs (standard operating procedures) and the accuracy of the estimations received from CROs, sites and specialized feasibility analysis firms as well as the potential value to be gained by engaging a specialized feasibility analysis firm under specific circumstances.

Both sponsors and CROs shared feedback on their experiences working with 23 different specialized feasibility analysis firms,

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