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.
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 for patient randomization and support in clinical supplies management.
BioClinica Data Operations director Kathleen Yeager noted this was a true partnership that extends beyond software products.
"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.
"It is very satisfying to be part of the drug development process, helping to bring new therapies and hope to people in need. 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," Yeager added.
BioClinica has supported Pharmacyclics research with eClinical technologies for multiple studies in Phases I, II, and III since 2010.
Imbruvica is indicated for the treatment of patients with mantle cell lymphoma or chronic lymphocytic leukemia who have received at least one prior therapy. Imbruvica is a first in class, oral therapy and is a new agent that inhibits a protein called Bruton’s tyrosine kinase (BTK).
BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B-cells.
Imbruvica blocks signals that tell malignant B-cells to multiply and spread uncontrollably. It is one of the first medicines to file for FDA approval via the new breakthrough therapy designation pathway, enabling Pharmacyclics to rapidly bring this medicine to patients in need.