Historically, life sciences clinical trial teams were pressed to visit trial sites according to a rigid site monitoring plan that requires equal attention be given to each site, regardless of need. This industry-standard, resource-intensive approach greatly reduces productivity, relies almost exclusively on manual assessments and gives equal weight to all data points. This old school approach is being left behind due to the acknowledgement that clinical trial costs are steadily increasing, and there is a great need to gain more data value for each dollar spent while not putting subject safety and efficacy measurements at greater risk.
Plugging in a system is not enough
As the excitement around RBM has increased, we have seen an explosion in the number of RBM solutions. This abundance in solutions has led too many companies into thinking that simply plugging a new tool into their eClinical landscape will allow them to realize all the benefits of RBM—if only that were the case. Your existing eClinical systems may already house the data that is necessary to start RBM, but adding the new solution to the mix needs to be part of a larger risk-based monitoring initiative.
CGI's clinical experts
CGI brings the experience, domain expertise, and a track record of successful implementations to our client’s projects. We have a unique
combination of clinical domain expertise and technical experience that will ensure a successful outcome.
Choosing a consulting partner who can help drive change in your organization is a difficult process. Our team of consultants come from a variety of backgrounds with the clinical domain in life sciences (Sponsor and CRO Clinical Operations, Sponsor IT teams, eClinical vendors, and consultancies) and have proven over and over again that our experience and expertise can directly contribute to successful client partnerships.