Our Process
Clinical research site operations do not readily lend themselves to measuring productivity or efficiency. Having a process which tracks productivity has to consider ever-changing workloads and the effects of complexity. Methods which merely measure complexity cannot, by themselves, determine productivity.
From a practical perspective, efficiency and productivity are synonymous; they calculate the amount of output (or product) for a given amount of input (or effort) over the same time frame. In clinical research, workload comes in two varieties. The work which results from recruiting study participants and generates revenue, which we describe in our first article as 'conditional' workload. Also, the effort required to keep the study operational independent of recruitment, which we call 'baseline' workload. An efficient site has a high ratio of paid to unpaid workload or of conditional to baseline workload.
Our data indicate that as CRC baseline workload increases so do recruitment and study visits up to a point, then adding more studies results in less recruitment and fewer visits. Though total workload increases, unpaid work exceeds that of work related to study visits. These CRCs appear very busy but are inefficient, and they can become frustrated and leave or burnout. Also, there may be quality issues further detracting from productivity. In a team approach, where a member other than the CRC recruits and sets the schedule, workload demands may exceed the capacity of the CRC. Resulting in both poor morale and study safety concerns. Ultimately, knowing when a CRC's workload is under or overallocated is a critical factor when assigning studies. Following performance and productivity over time for each CRC or team, shows trends and optimal study loads. When followed over time, this data determines the capacity of each CRC.
SiteOptex uses a proxy for baseline workload via a scoring tool which quantitates the complexity of each protocol. The software applies an algorithm to distribute this work effort over the course of the study. Moreover, accrued revenue is the proxy for paid effort (baseline workload). Study revenue is a valid proxy since study budgets are designed to pay more for more extended and complicated visits. By graphing accrued revenue on the y-axis of a graph to baseline workload on the x-axis for all studies on which a CRC or team is working, we can show the point of optimal workload. By viewing the data on these reports, site managers have the precise information required to determine the cause of any performance failures and to set the right course of action.
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