Performance metrics hold the key to study startup optimization
SAN FRANCISCO, June 25, 2018 -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today its latest version of goBalto Analyze. The second major release of 2018 offers new reporting capabilities based on standardized performance metrics that are actionable to drive transparency and process improvement.
The sharpening focus on quality management and efficiencies is fueling greater use of standardized metrics to optimize clinical trial performance. That's why targeted performance metrics that measure the many details of clinical trial operations are essential. And for study startup in particular, performance metrics are critical, given it is one of the most complicated parts of clinical trials and one of the most crucial to meeting site activation timelines and study completion milestones.
Performance metrics are critical to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages. They also drive competitive performance among those organizations performing trials.
Risk mitigation is therefore optimized using systems that can provide timely, preferably real-time data on trial bottlenecks, which indicate red flags to be reviewed and addressed or at least tracked carefully throughout the trial.
Jeff Kasher, President of Patients Can't Wait, and Executive Chair of the Avoca Quality Consortium, comments, "Turning big data into big insights requires analytics that are actionable. Performance metrics must be data-driven, standardized across studies, indication, and therapeutic areas, and timely. They must also, importantly, facilitate a forum for discussion."
"Although overall cycle times can be an indicator of process and team inefficiencies, it does not inform you as to the exact cause of the problem. Organizations need to be able to analyze their data to determine the cause and effect of process, staffing, and regulatory changes on their cycle times," said Sujay Jadhav, goBalto's CEO.
Having technology that can automate or assist in the timely monitoring of trials is a significant improvement over the current 'status quo' of manual methods, such as spreadsheets, which are cumbersome and erroneous, and unable to scale for complex global studies.
goBalto Analyze provides intelligence; presenting timely status updates across organizational studies and insights to streamline operational processes. Through visually rich analytics and dashboards, Analyze helps transition teams from a process that is reactive to one that is more proactive.
New standard reports improve the efficiency of the IP release process by quickly identifying sites that have not yet initiated package planning or those requiring additional follow-up, as well as funnel and milestone planning performance. goBalto also announces the industry's first, real-time benchmarking visualizations of study startup performance based on therapeutic areas and country.
Benchmarking of trial data allows clinical research teams to see at a glance if they are on par with past trials the organization has run of a similar size, geographic footprint, therapeutic area, indication, etc. If not, why? But equally as important, and arguable more so, is how does their performance compare against other organizations?
With over 300 pharma and CRO companies benefiting through a networked model using goBalto Activate to manage, track, and complete study startup tasks in thousands of studies, utilizing over 100,000 sites in 70+ countries, goBalto has the largest industry-proven set of country specific workflows and associated performance metrics.
As the only life science vendor having this depth of industry knowledge on study startup, goBalto is well positioned to standardize across multiple data sets, to provide a single view of the real-world metrics and cycle times. Study startup cycle time beginning, and end points have been defined in alignment with the multiple starting points defined by our customers. These are dependent on an organization's SOPs where, for example, the events Activated, IP release, and Site Initiated could be synonymous. "This supports our ability to provide an industrywide view of the cycle times important to study startup," said Jadhav. "Our business objectives are clear, to enable operational oversight across all CROs for a sponsor, enable artifact and milestone predictiveness, and enable TMF completeness and integration readiness."
"Benchmarks should be generated from standardized, well-conceived data elements and performance metrics," said Linda Sullivan, Co-Founder and President, Metrics Champion Consortium. "Additionally, the data needs to have sufficient metadata associated with it, so you can make meaningful comparisons and correlate benchmark results with best practice outcomes."
Benchmarking is the precursor to predictive analytics or forecasting, enabling clinical research teams to estimate future outcomes based on their current state of progress. "This is critical to risk mitigation and a preemptive weapon in the fight against the dreaded rescue study," stated Jadhav. "Our analytic capabilities are embedded into the business processes of leading life science organizations, pivotal to tacking entrenched pain points in study startup, reinforcing goBalto's leadership position as we continue to provide next-generation, industry proven study startup solutions."