One Week To EDC Database Go-Live

Executive Summary

Providence Medical Technology, a fast-growing medical device company with its headquarters in Lafayette, CA, was seeking a rapid and accurate method to collect data for its retrospective observational clinical study. They chose ClinCapture, perfectly suited for medical device clinical trials, and the only free validated EDC system on the market. Within two weeks, Providence Medical Technology was able to build its study, train sites, and start collecting data. “We were impressed how quickly we were able to begin data collection. The ease-of-use of the EDC platform ClinCapture and their excellent customer service really helped in achieving a fast start.”

Background | Medical Device Observational Study

A fast-growing medical device company focused on innovative, tissue-sparing spinal implants and instruments, was looking to conduct retrospective clinical research. The study involved a 100+ patient population who had already undergone surgical treatment with the company’s device. The device achieves indirect cervical spine decompression and fusion (DTRAX® Cervical Cage). With a limited, yet agile clinical department, it was critical for the sponsor to efficiently manage this process.

Challenge | Limited Resource, Experience and Budget

The Clinical Operations Manager, Jon Lyons, was responsible for the implementation of the EDC database, site training, data collection, and clinical data management activities. Lyons had no programming knowledge, no previous EDC experience, and limited clinical data management expertise. As a result, the sponsor was looking for an easy-to-build EDC platform with a short learning curve for sites and personnel.

Solution | 1 Week for Go-Live of the EDC Database

With no experience in building or using EDC software before, Jon Lyons was able to build and deploy a 20-page casebook clinical study within one week. This was possible thanks to the ease-of-use of ClinCapture’s Build Studio, allowing for fast ramp up even with no previous programming experience, as well as the user-friendly interface of the EDC platform, allowing for quick site adoption. With a short, two-page instructional document prepared by Lyons, sites were able to start collecting data quickly and effectively with no issues.

Providence Medical Technology was also able to get such results through the flexibility of a service package provided by ClinCapture, including a-la-carte support and a tailored training package matching the company’s needs and budget. Lyons leveraged the multiple resources made available by ClinCapture to build the database and train his sites, including the free community forum. Also, he quickly became involved with Marc Desgrousillier’s one-hour monthly online CTO TechTalk, where users have the opportunity to ask training and support questions at no cost. Furthermore, Lyons explains how ClinCapture was uniquely responsive to his suggestions for improvement within the CRF Build Studio, with feature enhancements being developed and released in less than three months following feedback.

Lyons leveraged the multiple resources made available by ClinCapture to build the database and train his sites, including the free community forum. Also, he quickly became involved with Marc Desgrousillier’s one-hour monthly online CTO TechTalk, where users have the opportunity to ask training and support questions at no cost. Furthermore, Lyons explains how ClinCapture was uniquely responsive to his suggestions for improvement within the CRF Build Studio, with feature enhancements being developed and released in less than three months following feedback.