Consultancy

Experienced project managers and expert operational teams are prerequisites for delivering effective and efficient setup and ongoing oversight of clinical development programmes. IXICO's processes reflect the importance of planning cycles, risk management and project governance in effective trial delivery, leading to confidence in the integrity of data handling, processing and analysis endpoint deliverables.

IXICO's collaborations with international consortia, academic institutions and global networks of research sites harnesses the best in imaging and other data science expertise to define, develop and validate therapeutic area specific imaging and digital endpoints in rare diseases.

Learn more about IXICO Collaboration initiatives HERE.

IXICO provide support/consultancy in protocol development to ensure tailored and well-defined imaging. A team of domain experts can advise on specific protocol questions during study planning, start-up and operations. Examples include the development and harmonization of bespoke fMRI, ALS and MRS protocols, advising on choice of imaging modality, endpoint selection, image reading paradigm, and imaging schedule.

It is important to establish a detailed imaging charter as evidence of standardization.  It is a regulatory document created to define and detail all aspects of the procedures that an imaging core lab performs to enable processing of image data and independent reads.  It should cover information on how potential sources of imaging bias and variability are controlled and how the standards are implemented to a level appropriate to the trial design.