We have rescued pivotal studies, reduced database lock by 1-4 months and saved millions in cost-overruns while reducing ineligible patients enrolled (<1% versus 7.5% - 15% industry standard) and helping 5 products get through approval.
After prior $10 million diabetes study failed due to 20% of enrolled patients being on exclusionary medications, Prevail eliminated ineligible patients from new study through a complex patient eligibility calculation after aggregating live data from multiple disparate data sources (labs, case report forms, interactive voice response system, patient diaries, and coded medications database) in order to immediately decide the right patients to enroll.
A pivotal 2,000 patient Phase III study was required to obtain approval of the Acne Drug. The trial would involve over 67,000 records and 800 adverse events. Moreover, the Customer had failed two previous clinical studies. In the first trial, a large CRO was used, and the trial failed due to a rater consistency problem. In the second trial, a small CRO was used, and the trial failed due to a mismanagement of the drug supply. Prevail was instrumental in assisting with enrolling and completing the Acne Drug trial nearly two months earlier than projected, while producing the highest level of data quality that supported an efficacy p‐value of 0.002.
A public, biotechnology company reported to the capital markets that the topline results of a Phase III study of its lead investigational drug would be released the first week of January, prior to the J.P. Morgan Healthcare Conference. About four months prior to the expected release date, the study was significantly behind schedule and its large, well known CRO informed the Company that the target date for topline results would be missed by a financial quarter. Prevail quickly performed an audit of the study to determine whether the timeline could be accelerated to meet the January deadline, and if so, to implement the solution. We designed, implemented and managed a timeline acceleration program that locked the database and produced topline study results a day earlier than originally planned. The Company’s market value increased 38%, or about $80M, when it was able to reassure the capital markets in mid-November that the January deadline would be met, and its market value increased 18%, or over $60M, when topline study results were publically reported on time in the first week of January.
After launching a study, Prevail worked with the sponsor to develop and obtain approval for multiple protocol significant amendments, a 10 patient sub-study, then re-launch the trial each time with minimal down time. While the sponsor provided the initial protocol, Prevail identified areas for improvement and provided vital feedback and ongoing data for appropriate amendments, allowing for an adaptive trial and versatility that was able to accommodate learnings. The different groups of patients were tracked under different amendments in parallel, while integrating all 5 databases and systems to make the trial data usable for the statistician.
Database was locked in less than 1 hour after receiving last patient data in pivotal study of 227 patients at 45 sites that produced high quality data (p <0.001)
Database was locked on the same day as last patient visit in a 450 patient, 10 countries, 50 site Phase III study that generated over 20,000 records
Suite of integrated clinical, logistics and financial oversight platforms were fully deployed in only 17 days in a large Phase III study, with the first patient enrolled on day 18.
Failed previous trial due to data inconsistencies
Medical device company
~6,000 queries, ~600 SAEs, FDA failure letter due to process issue
Failed Phase 3 causes 77% share price drop
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