Dedicated specialists focus on at-risk trials, driving toward new Oncology therapies
Bioclinica®, the worldwide leader in science-enabled medical imaging and core lab service supporting clinical development, today announces the formation of a dedicated team focused on Oncology rescue studies. The team comprises specialists with scientific, medical, Oncology and related domain expertise, as well as senior project managers and operational leads experienced in Oncology rescue studies.
"Due to their large-scale, global nature, Oncology trials tend to be difficult to manage," said Bioclinica's Medical Imaging & Biomarkers Chief Operating Officer Andrew Kraus. Compounding this, differences in type, location and progression of tumors require complex assessment criteria. "To combat these challenges and to address critical worldwide logistics needed for success, Bioclinica partners with sponsors to remove roadblocks to new Oncology therapies."
Bioclinica has more than 1,100 Oncology trials in its portfolio, including 64 U.S. FDA-approved Oncology therapies. The team has provided imaging core lab, expert independent review and supporting scientific services to sponsors from top tier pharmaceutical to smaller companies since 1990. Today Bioclinica is the leading imaging provider in the life sciences industry, offering comprehensive support in all trial phases for all major indications.
In recent years Bioclinica has been tapped to correct a variety of problems in Oncology studies including data loss from scans unable to be analyzed due to lax imaging quality standards on the part of inexperienced providers and those for whom imaging is not a core service. "It's something we avoid in our own studies by having stringent quality control and imaging standards to ensure data across all imaging modalities are acquired in accordance with the protocol and consistent across all time points, subjects and sites," Kraus explained. Aside from its imaging expertise, Bioclinica systems, infrastructure and proactive site management approach are credited by Kraus as key to obtaining the best quality imaging scans possible.
Bioclinica has successfully recovered 14 trials in just the past three years. In one study the sponsor was nearing database lock when they discovered their imaging provider was unable to deliver readings in time. Bioclinica helped the sponsor get out of an urgent situation so they could make their regulatory submission. Other issues such as variability in analysis can be avoided by having standardized imaging in place across all subjects and qualified, experienced reader management.
As imaging is a core specialty of Bioclinica, it has scale and dedicated, in-house readers — the most experienced in the industry. Medical Imaging has approximately 600 employees across its global and growing organization with a staff that includes radiologists, oncologists, data managers, technologists and project managers. The team has unmatched regulatory experience, medical leadership, operational excellence, and a large global workforce to meet the most challenging demands of today's Oncology trials.
"Our team understands the crucial operational aspects and what it takes to run a successful Oncology trial," Kraus commented. He added, "When Bioclinica steps into recovery mode, we do so with three decades of experience and a proven Rescue Study Plan of Action behind us. We work in close partnership with the sponsor to steer troubled studies back on course, paving the way to new Oncology therapies."
Industry professionals can meet with members of Bioclinica's Oncology rescue team at ASCO in booth 13099 through June 5 where Bioclinica is exhibiting and showcasing its Imaging Oncology services. Learn more about Bioclinica's Medical Imaging & Biomarkers business segment online, in the Bioclinica blog and on Bioclinica LinkedIn and Twitter channels.