Enterprise Application

Medical Device Manufacturer – Enterprise Application/Standardization

The client is a global, publicly traded medical device manufacturer focused on developing new capabilities in near-patient diagnosis, monitoring, and health management. They had achieved significant growth through acquisition and needed a way to standardize the collection and management of clinical trial data enterprise-wide.

This company had a vision to develop an in-house data management and bio statistic service bureau for the entire organization. Historically, each business unit would conduct its clinical trials independent of any set standard. This presented regulatory challenges, delays in data collection and analysis, and risk of unusable trial results.

For example, they discovered that one of their groups had been running a trial for two years and the data they collected on thousands of subjects was unusable. This was only discovered when they started to analyze the data. Upon further scrutiny, they found that the primary cause was an inefficient and outdated paper-based data collection method. The result was a potential loss of business in a very competitive market. Human error, multiple data entry, and mistakes using a paper-based resulted in additional study costs of approximately $1 million (US dollars).

Solution:

Simplified Clinical was contacted by the Director of Data Management and Bio Statistics for an enterprise-wide clinical trial data management system. Their strategy included standardizing Simplified’s Clinical Discovery Platform (CDP) for data collection and management along with a compliance-based set of documentation.

The Clinical Discovery Platform (SaaS) gave them the tools and the flexibility to support the unique requirements of each business unit while adhering to their newly implemented, regulatory compliance standards. By delivering quality assurance at the front-end, their internal service bureau is able to save the company time and money while improving the integrity of their data.

Cost was a major factor for this client and thus the requirement was put out to bid. Simplified Clinical was awarded the contract based on the quality of the technology and cost competitiveness.

Because Clinical Discovery Platform is a SaaS (software-as-a-service), what might have taken years to implement only took a matter of months. Working alongside this client, we helped them roll-out a regulatory compliant enterprise standard for both internal and investigational users.

Results:

  • Developed enterprise-wide regulatory compliant standard for how the client collects and manages its clinical trial data using Clinical Discovery Platform.
  • Helped the client establish their own central service bureau with compliance-based documentation and training.
  • Improved cycle time.
  • Improved data quality and accuracy.
  • Provided dynamic summary reporting to decision makers.
  • Reduced costs by eliminating human errors associated with paper-based redundant data entry.
  • Increased data management throughput without increasing staff.
  • Provided a central repository of clinical trial data that can be tracked, analyzed, and audited for historical trend analysis.

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