In the complex and costly business of running a clinical trial, maintaining control over a diverse and often geographically far-flung set of processes is critical to overall success. Clinical trial managers need detailed plans and clearly articulated processes—but they must also be able to identify challenges along the way and change course where necessary.
What confers this ability? For ophthalmic clinical trial managers, the tool is EXCELSIOR™, an FDA 510(k)-cleared, cloud-based application specifically designed to track and manage ophthalmic clinical trials. A portal for data collection and interpretation, EXCELSIOR™ also provides an accessible but secure, real-time window into a trial’s progress; allowing managers and other stakeholders to discover and defuse potential problems as they arise. Consider the following “choke points” in a clinical trial:
Clinical Site Training and Certification
To obtain trial data of good quality, the first step is making sure the study sites are appropriately staffed and equipped. Delays or significant challenges in this process must be addressed as early as possible, while time remains to make changes. EXCELSIOR™ makes granular data on site and technician certification readily available to assure trial managers that all is going well, or to spur them on to reparative action.
Depending on the nature and scope of the trial and its inclusion/exclusion criteria, recruitment can be challenged on a number of fronts. Getting the right number and mix of subjects requires resources, clear protocols, and informed practitioners capable of educating patients who might be candidates. Getting all of this to happen on time, further, requires oversight and troubleshooting, which EXCELSIOR™ provides: a simple, real-time report can show actual versus targeted recruitment across all study sites.
Of course, clinical trial data must be collected efficiently and in accordance with the study’s objectives and protocol. The right instrumentation and well-trained researchers lay a good foundation, but how can trial managers and other stakeholders be assured that data is sensible and reliable as it comes in? Too often, errors and issues in data collection are not revealed until data consolidation—when the opportunity to resolve the problem is long past.
Awareness of data quality, and of what the data reveals about the success or failure of the intervention under study, can significantly impact decision-making. EXCELSIOR™ brings this awareness and informs these critical decisions.
Even with careful planning, issues can arise at any point during a trial, carrying the potential for lost time and investment. By making it easy to see potential problems developing, EXCELSIOR™ can help ophthalmic clinical trial managers keep bumps along the road from turning into serious potholes.
Want to learn more about EXCELSIOR™? Contact Luca Sergio: (212) 791-1440.