Clinical trial monitoring is difficult and expensive, but key to a successful clinical trial. These five capabilities are key to a remote monitoring solution that lowers costs and makes clinical research easier.
The start of the CV19 pandemic sent sponsors and sites scrambling for remote monitoring options. Combinations of Zoom meetings, emails and eRegulatory binders held clinical trials together. Unfortunately, these solutions were often difficult to use, incomplete and had disjointed. Friction arose as we tried to make non-clinical software fit the specific demands of clinical research.
CROs, Sponsors and Sites no longer look for temporary measures for remote clinical research monitoring. Clinical research professionals seek new innovative and efficient ways to do research. Higher quality clinical research tools improve the quality of the clinical trial while reducing costs. Below are key components for remote monitoring solutions to become a new standard.
1. Virtual Meetings
Face to face interaction is a key component to monitor and site interaction. In camera-on meetings monitors can establish rapport, improvise to meet site needs and better understand clinical trial issues. In virtual meetings monitors can complete key objectives such as training, screen sharing, and reviewing important action items. Many virtual meeting platforms work well but few are purpose-built for clinical research regulatory requirements, compliance and security.
A virtual meeting alone is not a practical replacement to perform all site monitoring functions. Dependence on virtual meetings handicaps a monitor’s ability to perform other key aspects of a monitoring visit. For example, CRAs shouldn’t expect sites to perform lengthy and tedious over the shoulder document review in a virtual meeting.
2. Document exchange
Every monitoring visit requires exchanging multiple documents. When requested through e-mail or in person, inefficiencies build. People frequently lose, forget, or take a long time to respond to e-mail and verbal requests. Inefficiencies require redundant emails and communications to get results. A good remote monitoring platform allows monitors to share and request documents ahead of the monitoring visit. When document sharing is on a portal, all requested and shared documents are visible to the site and CRA.
Ideal document exchange platforms cannot lose documents, are visible to everyone responsible, and available ahead of a virtual visit. With document exchange handled prior to the monitoring visit, the CRAS focus on final tasks and review. Flexible workflows allow users to work when it’s most convenient and efficient for them.
3. Easier workflows
With increasingly complex clinical trials, both sites and CRA’s are strapped for time. Unless eClinical solutions are easier than existing solutions and processes, they won’t be adopted.
Remote monitoring solutions make it easy to organize, standardize and structure the routine aspects of monitoring visits so they are not repeated with manual processes. Frequently accessed study resources like the protocol and training documents can be just a click away. Creating easier workflows is a form of site engagement that lowers the barrier for sites to perform clinical trial goals.
4. Automated processes
Automating simple processes is the future clinical research. CRAs are familiar with many manual and redundant tasks required with monitoring visits. Administrative tasks like writing emails recording meeting attendance and following up with users take up precious time. With smart purpose built systems, these manual processes can be automatically completed by the system. Anytime a monitor is manually recording names inputting information or copy and pasting into a new document, there is a opportunity for a system to streamline that process. For example, setting an agenda creating and inviting users to a site visit are all functions that remembered by smart software.
A manual process that takes 15 to 30 minutes is just a few clicks with eClinical software. Plus, remote monitoring systems are customized to specific clinical research projects. Custom built platforms allow standardization and automation of tedious processes. Standardization and automation increases study quality while decreasing the workload on monitors.
5. eRegulatory and Source document binders
Electronic binder eRegulatory platforms are a key component to effective and efficient remote monitoring. Study sites should not perform redundant processes for CRA’s to access their documents. Ideally, sponsors and CRAs will set up eReg for all sites at the beginning of this study. With just one eReg and source document platform, all sites are accessed from a single login by monitors. By setting up eReg platform study the sites are better equipped to handle regulatory and source documents. Electronic binder platforms reduce work, improve quality and enable faster workflows for sites. A good regulatory platform will allow site flexibility to maintain their site specific SOPs and workflows.
A new way of doing things
MedPoint Digital is a leader in virtual meeting and eClinical solutions for the Biopharma industry. After reviewing the specific needs for clinical trial remote monitoring, MedPoint created the InSite Virtual monitoring platform.
InSite Virtual Monitoring is a one-of-a-kind solution to conduct virtual monitoring visits in a secure, intuitive, and fully automated environment. Built to each clinical trial monitoring plan, InSite reduces the work and burden on the CRA.
The InSite platform hosts secure virtual meetings, a document exchange portal and enables efficient workflows. These key automated functions make remote monitoring more effective than ever before.
InSite is fully integrated with Study eSafe, an eRegulatory and Source binder platform, that is free for sites to use for as many studies and users as they wish. Study eSafe gives monitors a single login to access all site documents. For sites, Study eSafe creates faster workflows and start up capabilities.
For more information about MedPoint Digital remote monitoring and eClinical solutions, contact MedPoint Digital today!