Studies
Cardiovascular Studies
Indication: Device
Type of Study: Longitudinal observational patient registry
Sponsor: Medical device company
Patient Population: 200
Investigative Sites: 100
The ViewPoint FUSE Implementation Team helped a major medical device company to help discover the value of aggregating existing information collected through their device. This study focused on the creation of an ad-hoc query engine and, also, the integration and consolidation of data collected through devices. The project included the following elements:
- Analysis of existing disparate data sources
- Database design to consolidate data and establish new data relationships
- Import mechanism to import, clean and process the data to the new database - including establishing new links between data points
- Online ad-hoc query interface for users to construct their own views of the data and its relationships
- Reports providing deep calculations that include individual row and column percentages for each cell and category roll-up summaries
- Reports readily exportable to Excel for easy printing, while also conducive for users to work with the raw data in other reports or systems.
Indication: Imaging
Type of Study: Longitudinal observational patient registry
Sponsor: U.S. pharmaceutical company
Patient Population: 30,000
Investigative Sites: 400
A web-based EDC tool was designed and hosted for an observational study of patients undergoing cardiac imaging. The web-based data collection technique allowed for the prospective capture of data from physicians and patients. Patients were followed every six months to determine long-term cardiac outcomes, as well as patient quality of life and satisfaction. Through the use of ViewPoint FUSE’s custom reports and benchmarking data, physicians were able to better understand and ultimately improve their delivery of care.
Indication: Cardiovascular
Type of Study: Observational patient registry
Sponsor: U.S. pharmaceutical company
Patient Population: 3000
Investigative Sites: 50
The ViewPoint FUSE Team partnered with a pharmaceutical company to launch a U.S.-based registry for a cardiovascular disease that was designed to follow 3000 patients for 5 years. Prior to finalization of the study protocol, the ViewPoint FUSE Team implemented a public website and an online clinical feasibility questionnaire to kick-off the program. The public website served to increase awareness of the disease and the sponsor's upcoming research program. A select group of potential investigators were given a password to a secure section of the website where they accessed an online feasibility questionnaire. The feasibility questionnaire facilitated the prioritization and selection of participating registry sites, as well as the collection of administrative data to aid investigator meeting planning and site initiation. The feasibility questionnaire automatically captured each user's internet connection speed and computer system settings to measure sites' capabilities to participate in the forthcoming EDC study. The website content was updated over time to communicate evolving study and disease-related information for participating sites and patients, as well as non-participating physicians and patients.
|
