Medical imaging is a key asset in the drug development process, and Keosys is committed to providing you with the best solution for your clinical trial, whatever its phase. For late phase trials, we use imaging data to provide efficacy evaluation for regulatory submission. For earlier trials, we leverage imaging to provide insights about the drug effects and the mechanism of action (MOA) to help you make scientifically sound decisions.
Our scientific team brings deep expertise in the medical imaging portion of clinical trials by providing the following services:
Each of Keosys’ central experts has more than 10 years of experience reading for multi-center clinical trials. Based in both the United States and Europe, these board-certified subspecialized experts provide you with the most accurate and up-to-date medical knowledge to secure and optimize the use of imaging in your drug development process. Keosys continues to grow its network of experts and Key Opinion Leaders (KOLs) through professional and research collaborations on an ongoing basis.
The Keosys scientific team selects central readers for your study based on the required therapeutic area, and manages those readers throughout the trial. In order to better understand the drug efficacy, it is critical to lower all possible bias and source of variability between each reader. To keep variability as low as possible, Keosys’ team monitors reading results over time, both for a given reviewer (“intra-reader variability”) and between reviewers (“inter-reader reliability,” “adjudication rate”) according to statistical indexes and metrics. Keosys also organizes consensus reading sessions and ongoing re-training sessions to keep the reader pool aligned and assign best reader pairs. When quantitative imaging is required, Keosys also evaluate measurements bias by using known size or density tools like phantoms.
Our team provides expertise on your imaging protocol design and tailors the reading scheme to your specific imaging endpoints. The team puts together Image Acquisition Guidelines (IAG), a document that outlines the required standards to get proper image acquisition consistency and reproducibility across each investigator site. The IAG addresses equipment standardization, imaging drug standardization, evaluation and mitigation of imaging risks (such as radiation exposure, contrast agent exposure, etc.). Keosys will also provide an Imaging Review Charter, a document that describes the imaging workflow, in order to ensure proper image management, a thorough review process, the selection and training of each person involved, and all other operational steps that can impact data integrity.