BioClinica Technology Supports Pharmacyclics in Achieving Early Approval of IMBRUVICA™ And Breakthrough Therapy Designations for Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL)
March 11, 2014
BioClinica®, Inc., a leading provider of specialized outsourced clinical trial services, today announced that its technology was utilized by Pharmacyclics, Inc. and supported the accelerated approval of IMBRUVICA™ (ibrutinib) for Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL).
The Phase III clinical program supporting IMBRUVICA’s early approval contained data that was collected and managed with BioClinica’s web-based solution and provided the Pharmacyclics team instant online access to review and analyze clinical data as it was captured in this global study, which involved 391 patients and was conducted at clinical sites in 10 countries. “Our partnership with BioClinica was important in ensuring collection of data from our clinical studies. We have utilized BioClinica’s technology now for four years and greatly appreciate the level of service and support we have received,” remarked Maria Fardis, PhD, Chief of Oncology Operations and Alliances at Pharmacyclics.
BioClinica’s technology enabled Pharmacyclics as well to maximize efficiencies in multiple study aspects with a high level view of operational data including study metrics and site status. A centralized clinical trial portal aggregated data from multiple data sources for real-time visibility. BioClinica’s technology was also used forpatient randomization and support in clinical supplies management.
“This was a true partnership that extends beyond software products,” said BioClinica’s Director of Data Operations Kathleen Yeager, CCDM. “We strive to give our customer all of the tools, training and resources needed for a well-run study and we stand by them every step of the way on through to regulatory submission.” Yeager added, “It is very satisfying to be part of the drug development process, helping to bring new therapies and hope to people in need.” Yeager explained further, “We knew the importance of the compound to Pharmacyclics so we provided solutions to decrease time and labor-intensive manual processes with automation everywhere possible.” BioClinica has supported Pharmacyclics research with eClinical technologies for multiple studies in Phases I, II, and III since 2010.
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