Client:

A mid-cap medical device company, founded in 1997, specializes in the design,
research, development and marketing of products to treat spinal disorders. Their goal is
to redefine the minimally invasive spine surgery market.

Challenges:

While the client is not a start-up, they are just beginning their venture into clinical trials
and have limited resources to devote to the clinical study process. The personnel in the
company’s clinical research department are best suited to the clinical and regulatory
aspect of running clinical studies; not the data management aspect.

How We Helped based on specifications created by client:

-Analyzed and reconfigured Clinical Data Management System (Medidata Rave)
-Managed the data validation process

Specification:

-Designed and implemented the data management plan and edit check
-Analysis and Annual Reports used for FDA review
-Facilitated data analysis and designed study outcome reports for the Interim
-Quality of data and reduced time spent on data validation
-Trained site coordinators on data management processes and tools; increased
-Worked as a technical liaison with Medidata
-Delivered high quality data within the budget requirements