"We have been very pleased with Fastphase's service level and support. Our protocol was implemented in the software in a matter of days, including all the edit checks, and it was delivered well in advance of the trial start date. Fastphase's efficient and intuitive interface required almost no training on our part. Our staff was up and running immediately."


CASE STUDY: Medical Device Company


This client is a leading medical device company conducting a clinical trial to test the effectiveness of a newly introduced medical device.

Sponsor's challenge was to identify a solution that could provide early trend analysis from early data capture. The solution had to allow for the capture of data during and after the trial. The solution needed to be more intuitive than paper CRFs and to require little or no training of MDs and clinicians.

Fastphase solution was selected for its very intuitive interface, its fast implementation and deployment, its low IT requirements, and above all its ability to view, report and analyze data. Fastphases solution was delivered as a full ASP software application hosted and managed remotely and requiring absolutely no new IT investment from the sponsor.

A Builder was used to design the interface from the existing protocol. The interface design included number of visits, tests to perform, forms to fill, edit checks definition, reports, number of users, role and privileges assignment, and more. All these components were designed to be reusable in future trials. The software was automatically deployed to each user so it could be used in an online and offline fashion.

The interface was designed in 2 days and the trial was ready to go in one week. The sponsor had absolutely no new IT investment to incur. Sponsor was able to leverage early data analysis from sites, and gather more complete data. Data was automatically cleaned. Sponsor time saved was about 40% compared to a typical CRF paper trial used today. More importantly, the sponsor was able to analyze trends early on, and make effective decisions.

100% sponsor satisfaction. The application was implemented and delivered very quickly allowing the sponsor to be up and running prior to the scheduled trial. The intuitive interface required very little training and accounted for 100% investigator retention. Protocol changes and software enhancements were implemented and deployed the same day they were requested. The integrated communication tools increased communication between all the clinical trial stakeholders (between sponsor and investigators, CRAs and investigators, data managers and CRAs, etc.) This increased communication was a significant factor in speeding up the overall trial.




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