Letting Investigators Lead
Flexibility is Key to CTMS Implementation
Data Integration: Past and Future
Photography: Getty Images
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Clinical trial research sites are at the ground level of clinical research, and are tasked with a myriad of responsibilities.
First and foremost, clinical research sites execute trial protocols while providing the best patient care and experience,
ensuring patient safety and gathering and providing accurate clinical data. Typically, sites are conducting multiple concurrent
trials, in various stages, from recruitment to trial close. Simultaneous recruitment of patients meeting different study criteria
is necessary. Patient visits must be scheduled and take place within time windows.
Regulatory compliance, IRB requirements, meeting milestones, and data gathering and reporting must occur. And trial finances,
including sponsor invoices, provider payments, and patient stipends must be managed. Added to these responsibilities are the
operational and financial aspects of running and managing a business.
Patient recruitment and site performance continue to be challenges, and the geographical scope and complexity of trials continues
to increase.1 The economic environment is driving increased sponsor focus on cost and timelines, and is resulting in delays and cancellation
of trials.2 This is directly impacting research sites. As a result, tools that facilitate communication, address workflow challenges,
improve economic return, and provide the metrics to demonstrate performance are becoming increasingly important.
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A clinical trial management system (CTMS) favorably impacts site efficiency and productivity by centralizing information—including
searchable patient databases and trial protocols—providing recruitment and screening tools, automating scheduling, managing
finances, and providing the reporting and metrics needed for business oversight and growth. The result is simplified workflow,
easier recruitment, optimum use of advertising funds, proactive management of finances, more productive staff, and ready availability
of proof points and metrics for sponsors.
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