Imaging CRO provides study endpoints in clinical trials which assist in determining the efficacy and safety of the drug therapy being researched. These endpoints which demonstrate the efficacy of a drug or therapy are assessed in most trials over long durations increasing the study period to years in some cases such as patient survival with serious and life-threatening diseases like cancer.
A GCP compliant image management platform (ERICA) supports the study to generate robust data to convince authorities and decision makers by reducing “data noise.
Biomarkers or any indicators that may help in predicting the clinical benefit though they may not be a measure of the benefit itself can help in demonstrating the results at an earlier time period and reducing the length of trial and costs. These markers can be used as surrogate endpoints, which may significantly reduce the time for confirming the clinical benefits of the drug and get approval faster.
Most important imaging techniques used in trials are MRI and PET. Magnetic Resonance Imaging does not involve X-rays. It is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body in both healthy and diseased conditions. Strong magnetic fields, radio waves and field gradients are used to generate images of the organs and structures inside the body. It is unsafe to do an MRI scan if the patient has medical implants or a non-removable metal inside the body. Certain atomic nuclei can absorb and emit radio frequency energy when placed in an external magnetic field.
Positron Emission Tomography is a nuclear medicine functional imaging technique that is used to observe metabolic processes in the body. Pairs of gamma rays are emitted indirectly by a positron-emitting radionuclide (tracer) into the body on a biologically active molecule for detection. Then, 3-D images of the tracer concentration within the body are constructed by computer analysis. In the new generation scanners, Computed Tomography (CT) X-Ray scans are used for this reconstruction performed at the same time on the same machine.
A highly specialized core and central lab services are imaging protocol development, support in defining imaging endpoints, site training, image collection and quality control, independent reader training, independent read management, statistics, analysis and reporting.
A proprietary "ERICA" image database and reading system ensures efficient processes and full transparency for sponsors. All services are provided in accordance with the FDA’s draft guidance (August 2011 and March 2015) for Medical Imaging in Clinical Trials.