Protocol Feasibility™ Assessment,” the newest tool from Provisio, Inc. (producer of HIPAA-conforming iTrials™ technology) helps biotech, pharmaceutical and medical device companies to accurately gauge the degree of a trial’s success before enrolling the trial (www.itrials.com).
The new iTrials service leverages the largest privately-owned resource in patient level study modeling: the iTrials Data Universe™ populated from more than 500,000 physicians with unique diagnoses/treatment histories for more than 60 million patients.
“Many clients are beginning to use this incredibly accurate iTrials innovation, which provides the “intelligent insight” to fully document a candidate pool that meets all clinical and demographic requirements,” says Mike Hassell, CEO of Provisio. “For the first time, trial sponsors can identify their most significant risks before dedicating resources or making significant investments. By executing trials virtually, iTrials brings important new capabilities to the clinical trial industry.”
The service includes:
A cross-referenced impact analysis that determines how each inclusion/exclusion criterion expands or shrinks the candidate pool
Identifying clusters of eligible candidates by geographic regions, media markets, metro areas, and other criteria.
Suggesting “intelligent locations” for potential study sites based on proximity to pre-qualified patient clusters.
Assessing recruitment timelines and enrollment probabilities based on the above and other variables.
“Clients receive a Trial Feasibility Assessment™ that translates protocol criteria into customized analytical procedures, situational assessments and data-defined conclusions, each tuned to reflect the sponsor’s business goals,” explains Hassell. “Applying iTrials proprietary weighting and scoring methodologies, we can rank and stratify eligible candidates in order of confidence.”
iTrials offers evidence-based site selection that virtually eliminates the guesswork of traditional site selection methods. Trial sponsors now can be armed with accurate information for selecting the highest producing sites, based on details of protocol criteria, patient availability, and investigator qualifications.
“With iTrials, sponsors can anticipate the rate of recruitment per site, assess and estimate site success, retention and efficiency –significantly boosting the potential for recruitment success,” says Hassell. “The Feasibility Assessment™ mitigates recruitment risks by enabling real-time adjustments to study parameters such as inclusion criteria, physician/investigator performance, local and regional media market metrics, proximity to required facility resources, and more.”
Additional services are also available including site proximity analysis, candidate cluster analysis and custom analyses based upon specific sponsor requirements and the unique needs of a protocol.
About Provisio, Inc. and iTrials
Headquartered in Nashville, TN, Provisio, Inc. develops technologies and services that enhance clinical trial processes. Its flagship solution, iTrials, automates and streamlines the way drug trial candidates are identified, notified and enrolled.