Medical Imaging Overview

Perceptive Informatics offers an impressive, sustainable track record of successfully applying and managing medical imaging in clinical trials. We are known for our medical, technology and regulatory expertise as well as our emphasis on imaging compliance and validation - key areas that require knowledge and expertise.

Clinical study sponsors increasingly rely on imaging as a surrogate endpoint in support of efficacy and safety. Our therapeutic and imaging experts provide a range of capabilities in the application of imaging techniques from early clinical development through peri-approval studies. Our clients are advancing clinical research through the strategic use of our significant experience in novel modalities to provide results that accelerate early decisions about therapeutic agents and decrease time and cost associated with clinical development.

Independent Review and Image Management Services

Perceptive offers the necessary operational and technological infrastructure required to conduct an independent review. Our in-house therapeutic and imaging experts have the knowledge and expertise to develop a well-defined, objective review process. Our imaging experts provide focused support as members of your project team to coordinate the independent review process including:

  • Standardization of imaging and image management at investigative sites
  • Image collection at a central location and management of the blinding process
  • Developing Independent Review Charters for review and approval by regulatory authorities
  • Subcontracting Independent Reviewers and training these reviewers on the assessment criteria and reviewer roles and responsibilities
  • Managing the logistical processes involved in the independent review

See Also

Guidance on assessment criteria for NHL and CLL