Observational studies
Observational research studies seek to look at the effect of an intervention or treatment without any intervening in the standard of care. This can be done as a case control study, a cohort study or a cross sectional study.
Cisiv offers a suite of electronic tools which transforms the way observational studies are run. Built from the ground up to collect longitudinal data, Baseline Plus offers many advantages over e-Clinical systems. Baseline Plus is perfect for undertaking natural history or drug treatment studies and building registries. Click here to find out more about electronic data capture.
The technology is fully industrialised and has been developed to optimise data quality while reducing the manual burden for both a site and data manager. Most manual activities can be replaced by robotic process automation and intelligent algorithms.
The advantage for a pharma or medtech sponsor is a more efficient process to help them obtain real world data.
Most clinical systems have been built to support the processes of a rigid clinical trial. Observational studies require flexible technology which drive a different set of processes.
Cisiv has supported some of the largest web-based cohort research projects, with up to 20,000 patients, which ran for over 10 years. These studies span 19 countries, in more than 8 languages. Baseline Plus has an embedded safety module which enables safety event identification. This can be reported by physicians or triggered by other factors in the data.
To discuss the type of observational research study you should be creating to address your real world evidence needs, speak to an expert now.