MEDIDATA offers end-to-end imaging solutions from study planning / protocol development over image collection and processing to the organization and conduct of central image reviews.

Our services include:

• Study Planning and Set-Up
  • Design and Review of Imaging Endpoints and Image Acquisition Protocols
  • Development of Imaging Site Manuals
  • Site Qualification: Technical Site Evaluation and Staff Training
  • Development of a Central Review Charter

• Conduct
  • Image Tracking and Collection (Electronic Transfer Methods or Courier Mail)
  • Quick turnaround times: Semi-automatic Image Quality Checks & Query Process
  • Image Blinding & Processing for Central Review
  • Daily updated, web-based Reporting of Study Progress
  • Parameter Imaging Analysis

• Central Review
  • Technical Setup of Central Image Review in house or remote
  • Central Reviewer/Reader Selection and Training
  • Reader network with subspecialized, board certified radiologists
  • Conduct Central Image Review
  • Central Review Data Management
  • Image and Central Review Result Transfer and Archiving
  • Optional eCRF
  • Implemented Audit Trail
  • GCP and 21 CFR Part 11 compliant
  • Wide variety of criteria covered: RECIST 1.0 and 1.1, Choi, Cheson, irRC, RANO