ICTI Expert Hosts Roundtable at FDA Conference
September 14, 2005
Eva Miller, Ph.D., the Manger of Biostatistics at ICTI, is hosting a roundtable today at the 2005 FDA/Industry Statistics Workshop. Dr. Miller will discuss adaptive trial designs, which ICTI facilitates for clinical sponsors through the use of its IVRS and EDC technology.
Adaptive trial designs allow modifications to be made to a clinical trial after patients have been enrolled, without compromising the scientific integrity of the trial. In adaptive trials changes such as dropping a treatment arm, modifying sample size, and balancing treatment assignments using adaptive randomization can occur. As a result of implementing these designs, sponsors can sometimes consolidate phases II and III.
Valarie Higgins, ICTI’s Vice President of Client Services, notes,
“Our clients really appreciate our ability to help them reduce costs and accelerate their clinical programs through use of our adaptive trial design enabling technologies, IVRS and EDC. Equally important is the advantage adaptive designs can have for clinical trial subjects when ineffective treatments are discontinued before the conclusion of a trial. It’s fantastic to be able to create benefits for everyone involved. “
About ICTI and Almac Sciences
ICTI is a division of Almac Sciences that specializes in interactive solutions to accelerate the clinical trials process and reduce the costs of clinical trials. Our solutions include Interactive Voice Response (iVR) for patient randomization, dosing and clinical supply management; iDiary phone-based patient diaries; iTrial EDC for clinical trial data; and forecasting for clinical trial materials planning. Almac Sciences and its affiliated companies (CSS (Chemical Synthesis Services), CTS (Clinical Trial Services), ICTI (Interactive Clinical Technologies Incorporated), PDMS (Pharmaceutical Development and Manufacturing Services) and ArraDx (Array Based Diagnostics)) provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, manufacture of API, clinical trials and drug product manufacture. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh.
Contact Jim Murphy or Anne Zielinski US: 267-685-4284 [email protected]