Monitoring is one of the most expensive items of every clinical trial budget. And on-site monitoring requires the most of resources, although it does not have a crucial and direct effect on the quality of data collected. In the meantime, with the latest GCP R2 regulators encourage everyone to “lower the costs of drug development while increasing the quality of data”.
Data Management 365 has always been focused on methods to make drugs more affordable. In other words, we focus on software development as well as methodology development for cutting-edge practices for our customers’ processes.
MainEDC™ + MainEDC eСOA + Risk Based Monitoring + Remote Monitoring + Clinical Data Science
The above combination of practices is exactly made to reduce costs of monitoring and the clinical trial overall through regulatory-acceptable methodology. The complex of technology and regulations allows hybrid approach for clinical trials. And we help our clients realize any aspect of remote monitoring implementation in their companies, applying not only technology, but necessary updates to the quality system according to regulatory requirements.
This practice was successfully proven in one of the biggest projects in the world conducted on our platform. It was also highly ranked during on-site inspections by regulators and remote audits of Data Management 365.
We plan to continue actively developing the MainEDC ecosystem and strengthen the role of Clinical Data Science in processes offered to our clients for their clinical trials.
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