Global Services with a Local Face
Medifacts’ offices in Rockville, Maryland, USA; Langenfeld, Germany; and Shanghai, China allow for around-the-clock operations and regional project teams. Medifacts’ staff is composed of trained professionals involved in clinical trials in centers across six continents.
Medifacts has experience implementing multiple technologies around the globe providing familiarity with thousands of clinical sites, a variety of indications, and experience with country-specific logistical challenges. This extensive experience enables Medifacts to assist and guide our partners to more effective and successful project deployments and completions.
Medifacts can provide a full range of services in support of cardiovascular safety data collection, including:
- Standardized equipment programmed with site and study-specific details
- Configurable data management platforms eliminating programming and validation and allowing for rapid study startup
- Comprehensive, hands-on training of equipment and procedures offered at the Investigator site, at Investigator Meetings, or via web/teleconference
- Site support -- 24 hours a day, 7 days a week, 356 days a year
- Digital data collection, transmission, and analysis
- Ongoing query generation and resolution for rapid study closeout
- Data submission available in a variety of formats including FDA XML
- Statistical Analysis Planning and Biostatistics in support of Cardiovascular Safety data
- Expert interim reports
- Expert Summary reports for inclusion in the overall Clinical Study Report
The primary mission of Medifacts’ team members is to support the acquisition of data necessary to determine the safety and/or efficacy of drugs or devices involved in clinical trials.
Medifacts International has been instrumental in shaping the industry by helping to set standards of quality and unsurpassed service. Today, as cardiovascular experts with international reach, Medifacts continues to lead the industry by upholding this standard of excellence.