Documentation Services
Before a clinical trial begins, the imaging procedures and review methodology must be precisely defined and documented. Medwave prepares the study-specific documents that govern how imaging is acquired at sites and how images are reviewed centrally — ensuring consistency from the start.
"Well-prepared imaging documentation is the foundation of a reliable central review. Ambiguities in acquisition or review methodology, if not addressed upfront, inevitably surface as data quality issues during the trial."
Imaging Acquisition Guidelines
Protocol Design
Study-specific imaging acquisition guidelines tailored to the modality, indication, and response criteria used in the trial.
Scanner Requirements
Definition of minimum scanner specifications, sequence parameters, and technical requirements for participating sites.
Site Harmonisation
Standardisation strategies to minimise variability in image quality across multi-site and multi-vendor environments.
Methodology Review Documents
Review Charter
A formal document defining the central review process, reader roles, adjudication procedures, and applicable response criteria.
Read Methodology
Specification of blinded vs. unblinded reads, independent vs. consensus reads, and the handling of discordant assessments.
Criteria Specification
Detailed specification of the response criteria to be applied — RECIST, RANO, Lugano, iRECIST or custom criteria — with protocol-specific adaptations documented.