Studies

Infectious Disease Studies

Indication: Infectious Disease exposure

Type of Study: Prospective, observational, exposure-registration pregnancy registry

Sponsor: CRO

Patient Population: 14,000

Investigative Sites: 380

The ViewPoint FUSE Team partnered with a CRO and eleven sponsor companies to support an existing long-term, prospective, observational pregnancy registry. Data collection for the registry was ongoing for almost a decade prior to the ViewPoint FUSE Team joining the project. Existing data was migrated into the EDC solution. An EDC solution resulted in a decrease of the data entry and data management burden at the CRO. System design included multiple Project Management and Data Management Reports, along with on-demand access to all clinical data.