Our Proprietary System, Your Journey Looks Even More Promising
Medical imaging is a powerful, cost-effective tool for accelerating your journey. Using medical imaging as a surrogate endpoint lets sponsors “see” the effect of a new drug much earlier than traditional endpoints, like clinical benefit or survival times. It also offers effective support for your important “go/no-go” pipeline decision-making.
PAREXEL Informatics is a global leader in helping pharmaceutical and biotech companies employ time- and budget-saving medical imaging in clinical trials.
Our expertise spans a wide-range of therapeutic areas and indications including Oncology, Musculoskeletal, Neurology and Cardiovascular. We have a proven track record of delivering standardized image acquisitions, rigorous analysis, and quality endpoint data through validated techniques and tools. PAREXEL Informatics’ full range of services comprises all necessary pieces for successful trial imaging implementation. These include protocol/study design and charter development, site qualification, in-house image QC, independent image reading and analysis, data reconciliation and export, final archival, regulatory support, and submission.
Our Medical Imaging experts also provide:
• Standardization of imaging and image management at investigative sites
• Image collection at a central location and management of the blinding process
• Development of Independent Review Charters for review and approval by regulatory bodies
• Subcontracting of independent reviewers and Training on assessment criteria and reviewer roles and responsibilities
• Management of logistical processes involved in independent reviews
Our proven systems and processes enable complete collection of high-quality images. Our capabilities include: investigator site qualification including test data capture, electronic data transfer integrated with our tracking system, development of standardized image…
External Expertise – Scientific Advisory Board. The PAREXEL Informatics Scientific Advisory Board is composed of highly skilled Physicians and Scientists with a broad range of experience and expertise. These professionals work in academia, hospitals, in the CRO industry…
Our medical imaging consulting group features a world-class team of therapeutic, imaging, and regulatory experts. They offer focused support as members of your project team, and can make your next study more effective and cost-efficient -- from initial planning stages through FDA approval…