Medical Device Manufacturer

CASE STUDY

Medical Device Manufacturer Regulatory Compliance Applications

Client Background

This European company develops, produces, and markets innovative devices for mechanically supporting the heart, and has developed a niche in pediatrics. Their products are known by cardiologists (where approved) to be highly reliable and engineered for utmost precision. With a solid position in the market, they have identified strategic international expansion with three of the world’s leading heart centers.

Challenges

The client came to us through a referral and had little time to get the study database designed, tested, and implemented. They realized that they needed to provide extensive trial data and flexible reporting while meeting government and regulatory standards for privacy and reliability. With few internal resources and a tight deadline, they contacted Simplified Clinical.

Solutions Implemented

With over a decade of experience helping medical device companies collect, manage, and analyze clinical trial data, the Simplified Clinical team was able to fast-track the project to meet their critical deadline. With our latest version of the Clinical Discovery Platform, we quickly turned around eCRF prototypes for client review. Furthermore, the extremely intuitive interface allowed for rapid web-based investigational site training.

Results

  • Within four weeks, they implemented a fully tested, regulatory compliant, electronic clinical trial data collection platform.
  • eCRFs and study database was ready for first subject enrollment.
  • Client was able to stay within their original budget.

Results, Simplified

Simplified Clinical works alongside sponsors, CROs, consortiums, and consultants from around the country and world to implement a standard platform to maximize clinical trial results, and their CDP is customizable for maximum efficiency when collecting and reporting on integrated clinical trial data.