Successfully managing Clinical Research Associate (CRA) site visits is a critical part of any clinical research organization. CRA monitoring, while a mandatory and non-negotiable part of managing and monitoring a clinical trial, has a very real impact on the daily work of your site. Therefore, minimizing daily work disruption, optimizing resources spent on site visits, and demonstrating partnership with the monitor are important elements of running a successful Clinical Research Organization (CRO). There are some key ways you can minimize CRA site visits costs and disruptions that can be implemented by any research organization.
Perhaps your best tool to minimize CRA site visit impact is a transition to digitized regulatory management. Research sites that have shifted to digital solutions for regulatory management have optimized resources, freeing up staff time to focus on patient-care and revenue-producing tasks that maximize productivity, accuracy, and profitability. The transition away from binders and paper management has a direct impact on how your research site manages site visits. It’s challenging to track every process that goes into the daily work of a research organization; by moving your regulatory management to a digital eBinder system you’ll be able to better track activities, time, and results for CRA site visit reviews. Further, with all of this data in an easy to access digital form, your team won’t have to spend precious time organizing binders or decoding paper management systems for monitors.
CRAs have the responsibility to ensure all elements of patient safety, clinical data accuracy, and investigational protocol adherence. With that in mind, what can your site team do to evolve your approach to CRA visits to one of partnership? CRAs and site monitors are increasingly comfortable with digital regulatory practices so having the best system to track data will help make their job easier, often meaning an easier site visit for your organization and team. Early communication with monitoring organizations to alert them to your Clinical Trial Management System (CTMS) and eRegulatory system configurations will allow their CRA staff to better prepare for visits to your site. Likewise, understanding specifically what they expect on-site allows your team to proactively prepare versus spending more time on last minute requests for data. And even when those ad hoc requests do arise, a digital system in place will enable finding and distributing the data in less time.
Ensure your team understands how digitizing regulatory management will affect their work when it comes to CRA site visits and FDA inspections. Digital records will make preparing for inspections less time-consuming and potentially reduce the amount of time inspectors are on site. However, focusing on this element of the digital transition during planning and implementation is a critical piece of a successful eReg solution. Make CRA visit preparation a consideration when evaluating the deliverables and reporting needs of the transition to digital regulatory management. How might the very specific CRA requirements affect the process? Engaging your eReg partner in these discussions will be critical so they can help ensure you’re building a system that addresses the needs of both internal and external stakeholders.
Check out our latest guide “Five Steps for Digitizing Regulatory Management” to help you better prepare for future CRA visits. If you need help selecting the right system and transitioning your work processes, request a demo of our powerful eReg or other eClinical solutions.