Pharmanet

Client:	A global pharmaceutical company conducting a large, Phase II, multi-stage oncology study.

Challenge:	The client wanted an integrated solution that included Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and Integrated Voice Response System (IVRS). The solution needed to screen study participants into multiple stages of the study, randomize and un-blind participants, and collect electronic Case Report Forms (eCRFs). The solution was also required to ensure rapid exchange of records among the EDC, CTMS, and IVRS systems, to avoid duplicate data entry and to unify reporting.

Solution:	The study employed a PharmaSoft solution comprising EDC, CTMS, and IVRS. PharmaSoft’s integrated design enabled seamless exchange of information among the systems. Participant screening for each phase was accomplished when eCRFs were filled out for each visit, with the screening information transferred to IVRS in real time. Participant randomization was performed when investigators called the IVRS. Randomization information assigned by the IVRS was directly transferred back into the corresponding eCRF record, avoiding duplicate data entry. Web-based reports on information contained in the EDC, CTMS, and IVRS was accessible to site and client personnel, as well as PharmaNet monitors.

Outcome:	A fully integrated clinical-trial information solution enabled this sponsor to save time and money by using single data entry through a combination of web and telephone interfaces.