Enrollment Cycle Times Can and Should Be Optimized, and people can and should be hold accountable to deliver it.
(PRWEB) January 23, 2018
PhESi for the first time in our industry was able to accurately forecast the enrollment cycle time for the largest randomized phase 3 clinical trial for a hematology indication, by leveraging its database, the largest in the industry, and its proprietary platform created to interpret the data.
The details of the PhESi project is explained in a peer-reviewed article, just published in Applied Clinical Trials on its website: (http://www.appliedclinicaltrialsonline.com/enrollment-cycle-times-can-and-should-be-optimized).
It is not possible to shorten enrollment cycle time infinitely. Adding investigators can initially reduce enrollment cycle time, but the benefit diminishes quickly. Beyond a certain point, adding too many sites complicates the operational environment and unnecessarily prolongs enrollment cycle time.
The PhESi platform takes an integrated approach. Utilizing a patent-protected method and combining relevant historical data, we objectively define an operational baseline. From that baseline, PhESi incorporates various factors impacting operational deliverables, such as investigator site performance, site activation, inclusion/exclusion criteria, along with other protocol design elements and objectively sets expectations for various functional groups responsible for the operational deliverables, including enrollment cycle time.
Using a similar approach, PhESi also helps its clients in areas such as clinical trial design optimization and integrated clinical development planning. In a recent project, PhESi helped one client to take a development pathway that saved at least $46 million, while achieving similar regulatory objectives.
PhESi is currently working with clients ranging from pre-clinical start-up biotech companies to top 20 pharmaceutical companies. The work is across a number of disease areas and trial phases. For more information please contact us at info(at)phesi.com.