eRegulatory software is a game changer for clinical research sites in terms of digitizing regulatory management. Replacing bulky binders with easy-to-navigate resources accessible by any computer connected to the site system saves time, enables multi-site efficiencies, and ensures accuracy of the data. But as you consider an investment in eReg, you should look beyond its benefits to your site and consider how sponsors would benefit from its implementation. With direct sponsor benefits, sponsor support should also be considered as a way for your organization to fund an eReg system. Making the case for sponsor support is best done through a comprehensive ROI justification that tackles key areas of sponsor interest.
Mitigating risk is perhaps the most significant financial benefit your site can provide to a sponsor through the implementation of eReg. eReg automates several processes, which makes tracking easier and reduces the risk of errors associated with manual methods. Increased efficiency and improved accuracy can lead to better results and elevated sponsor satisfaction. Increased compliance has real financial benefits which should be outlined in sponsor proposals.
Expanded Study Capacity
Clinical research organizations, even those with multiple sites, have a defined capacity for study management. This often means that sponsors need to partner with an increased number of sites to get the study numbers they need. Specifically for multi site management, eReg enables oversight at scale, a benefit that no manual reconciliation can offer. Reducing “busy” work in this way enables your clinical research office to take on more studies and provide sponsors with better return on their investment.
Improved Site Visit Efficiency
A significant amount of sponsor time during a trial is spent on site inspections to ensure all elements of patient safety, clinical data accuracy, and investigational protocol adherence. Digital records will make preparing for inspections less time-consuming and potentially reduce the amount of time inspectors are on site. This has very real financial benefits for sponsors and one that you can clearly convey ROI. Work with your team to calculate end-benefits and incorporate eReg’s effect on CRA visit preparation as an element of study applications.
The Bio-Optronics eReg team can help you calculate both site and potential sponsor savings with a switch to digital regulatory management. Contact us to get started.