Multi-Trial Data Integration: A Case Study

 

ICON Clinical Research and IVRS were awarded a pivotal Phase III study, with more than 19,000 patients in over 35 countries from a top ten pharmaceutical company.

 

The Challenge

The primary challenge was the integration of a randomization and drug management system with the eCRF and CTMS. The sponsor did not want paper so each transfer had to be bi-directional. The sponsor also committed to full web-based electronic data capture in all Phase II and III trials.

 

The Solution

The primary system used was IWR; with the IVR system (telephone) employed simply as a back-up for sites. An XML data transfer process was designed to transfer data between the various systems. A process of separate dispensing and verification “calls” for sites was implemented to utilize the client’s new packaging standards, whereby each pack of drugs has a unique number for retrieving it from the pharmacy and a verification code that is reported when the drug is actually dispensed to the patient, reducing the risk of mis-dispensing.

 

The Outcome

Twenty-two web reports and more than 100 email and fax SMS alerts were designed to keep the study team up-to-date. With a much larger team accessing the ICOPhone data, the number of users accessing the system increased substantially. In managing medication supplies at the sites, the system uses predictive modeling to re-supply each site according to ongoing patients and expected recruitment; reducing the drug required (and the associated costs) significantly. Requests for shipments to sites are no longer paper requests; instead requests are sent as encrypted electronic files that are instantly uploaded into the depot’s database, eliminating the need for data entry of the shipment request.

 

It is these changes in data integration that are perhaps the most striking. In addition to sending medication supply requests electronically in real-time, ICOPhone and the eCRF (RAVE) send and receive patient data in real-time, 24/7, using a standardized data transfer engine between the two systems. ICOPhone also receives all site and user information directly from the client’s CTMS. By eliminating most of the paper and manual processes, ICON Interactive Technologies has saved the sponsor time during the trial and when it is completed, there will be no data cleanup required, thus reducing the original timeline of this study.