The North Carolina contract research organisation (CRO) estimates that site monitoring, including travel and assessment, can account for up to 80 of a trial’s budget, particularly given the growth of multi-country studies.
The module, which is designed to streamline the monitoring process, collects and presents site performance data to sponsors via the web in an approach that, the firm claims, “[produces] faster, more accurate results with fewer wasted resources.”
It also schedules inspections based on the amount of work conducted at a particular site, thereby avoiding arbitrary visits to locations that may not have amassed a significant quantity of data.
Health Decisions COO Rick Farris explained that efficiency was the key motivation for developing the new extension.
“For a clinical trial to be truly efficient, every person working on it must have access to the right information, which includes both performance data and meaningful analysis, as quickly as possible.”
“By granting monitors the ability to continuously refine the trial’s operations within the limits of their role, HD360˚ and our Agile Clinical Development platform allow every study to benefit from efficiency-boosting adaptive techniques with no added risk to data integrity or patient safety.”
He went on to say that Monitor View is already providing benefits for trial monitors, both in day to day operations and overall trial performance.
Sites, investigators and sponsors
The new module is the second extension of the HD360 system after the aptly named clinical investigator monitoring tool “Investigator View”, which was launched earlier this year and has since been upgraded with “sleeker reports” and “search filters.”
The third and final update, scheduled for release in 2010, “Sponsor View” is designed to enhance reporting and data analysis and will, according to head of Heal Decisions IT department Maurice Hagar, complete HD360 as a trial management hub.
“Each study role, investigator site, monitor, sponsor and every function in between, will be equipped with information to more actively contribute to the study’s overall success.
“The end result is an unbroken stream of data handled as efficiently as possible from start-up to database lock and beyond, letting us take advantage of every opportunity to make our sponsors’ programs run faster and more smoothly.”