Inference Systems (ISYS) is a global core lab services partner offering imaging trial management, endpoint validation and regulatory approvals for global clinical imaging trials. As a core lab service provider and partner ISYS takes an in-depth approach starting for a thorough assessment of the disease area being explored to leveraging novel imaging endpoints to build smaller and faster clinical trials across disease areas. A dedicated team of imaging scientists at ISYS work with key opinion leaders around the world to support sponsors with relevant validation data and background material to select patients and plan their studies.

ISYS has extensive and in-depth experience with imaging in respiratory diseases such as COPD, Asthma, Cystic Fibrosis, Pulmonary Thromboembolism and IPF. ISYS has worked different parenchymal, bronchial and mediastinal endpoints in respiratory diseases in clinical studies. The range of clinical studies in respiratory disease area includes method studies, device trials and phase 2-3 small molecule based studies. The modality expertise in lung diseases spans different variants of CT, MRI, PET and Chest Radiographs.read more

ISYS core area of expertise in cardiology is in atherosclerotic plaque imaging using different modalities like CT angiography, MRI, Nuclear medicine etc., A recent study using IVUS is the first engagement in this novel modality. Vascular imaging and CT in Stroke is fast becoming an accepted a gold standard in clinical practice. ISYS has core expertise with imaging in cardiac rhythm disorders such as atrial fibrillation and tachycardia.read more

Solid tissue imaging is widely used in clinical trials and there are several approved imaging endpoints like RECIST. ISYS expertise is limited to few cancer types including lung cancer, colorecetal carcinoma and prostate cancer. ISYS has developed novel methods for interpretation of Dynamic Contrast Enhanced MRI (DCE-MRI) for quantifying k-Trans, AUC and other variables. ISYS has in-house radiologists trained in review of oncology studies using different assessment criteria.read more

ISYS has worked with world leaders in amyloid imaging and structural imaging of neurodegenration in clinical studies. PET imaging is a standard practice in both drug localization studies and also efficacy studies. ISYS has been involved with longitudinal population based studies for cognitive impairment including MCI. PET based therapeutics and ligands have been tested in different preclinical and clinical programs in partnership with ISYS.read more

ISYS expertise with musculoskeletal disorders is limited to Osteoarthritis, Osteoporosis and Rheumatoid Arthritis using MRI and CT as core modalities. ISYS has a unique position in myopathies with its proprietary imaging technique for estimating degeneration and functional impairment in myopathies.read more

ISYS has expertise in the broadest spectrum of imaging ranging from invivo molecular imaging with nano particles, preclinical imaging and clinical imaging. This brings enormous value to the sponsors and partners to build a successful imaging strategy starting from the target identification phase and translation in the preclinical environment and there on to the clinical application. Partnering with ISYS helps sponsors to front load application of imaging modalities and build a regulatory evidence base moving forward.read more