Bioclinica sponsors receive high-quality, efficient, and compliant services that flex for complex, multi-faceted studies.
In the past, when biopharmaceutical professionals went looking for cardiovascular imaging (CVI) services, they likely searched for a service combining standardized procedures for data acquisition, processing and management, careful adherence to regulatory requirements, strong project management, and ongoing site support.
But these days, they need more. Studies have become so complex that cross-indication and multiple-modality expertise is no longer nice to have; it’s must-have.
“We’re an iCRO, or Imaging Clinical Research Organization, and therefore need to be able to do more than a one-track clinical trial,” said Elizabeth Gregory, Senior Research Technologist, Scientific Affairs, Bioclinica Medical Imaging (an ERT company).
“Our portfolio of service offerings shows the flexibility and rigor we apply to sponsor projects,” said Blaine Horvath, also a Senior Research Technologist in Scientific Affairs at Bioclinica. “We are flexible in adapting to sponsor needs, and multi-modality studies fit us well.”
As an example of a multi-modality study, he mentioned an oncology study that also has a component of cardiac safety and efficacy. To illustrate the rigor applied with sponsors, they both described how Bioclinica follows imaging site qualification and review procedures that include:
- reviewing the equipment capability at all sites that will scanning subjects so Bioclinica can identify potential technical issues early in the process,
- following SOPs for receipt, tracking, archiving, and backing up of images and study data,
- assuring the quality of images meet the assessment criteria of the protocol and providing feedback to sites to improve for future scans,
- comprehensive training of site technologists, central reviewers, and study personnel, and
- performing edit checks and reconciliations on the data by dedicated clinical data management teams prior to transfers to sponsors.
Their teams have over 40 years of experience looking across multiple modalities, Blaine said. Staying up to date with regulatory requirement changes, and working within high-quality and regulatory compliant systems for collecting, standardizing, and analyzing images in a multi-center clinical trial setting are key to a successful delivery to sponsors.
Bioclinica’s fully integrated end-to-end solution, with clinical imaging technology that enables compliant electronic image submission and analysis, is conducted by an imaging team that includes medical experts and globally recognized key opinion leaders.
The Bioclinica approach has worked in more than 70 countries, spans the complete clinical trial lifecycle, and encompasses the oncology, neuroscience, musculoskeletal, hepatology, gastroenterology, and cardiovascular therapeutic areas.
“We’re proud of our teams and the methods we’ve perfected over the years with our sponsors,” Beth said. “And we look forward to working with more companies conducting multi-phased clinical studies as they search for solutions for serious health issues.”