Clinical Development

Working together

With many years of experience in supporting regulatory compliant clinical research, we are ideally placed to advise our clients in making more informed decisions around the selection and use of imaging and digital biomarkers.

We can work as an integral part of our clients' own teams and within collaborative consortia to identify, develop and deliver solutions that reduce risk and increase the impact and value of our clients' assets.

Imaging Strategies

We can define an appropriate imaging strategy to optimise and de-risk deployment into your clinical trial. Our expertise includes structural and functional MRI, PET and SPECT.

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Retrospective Analysis

We can apply analytical capabilities to perform analysis of clinical data, improving the reliability of endpoint measures, or providing better clinical trial efficiency through screening & segmentation stratification.

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Digital Biosensors

We can advise on the suitability of digital biosensor measures to improve the measurement of clinical outcomes, and how to successfully use these measures in registration studies in a regulatory-compliant manner.

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Operational Excellence

Entrust an expert operational team you know will deliver reliable, consistant results

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.

Working Collaboratively

Progress clinical development through the power of collaboration

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.

Protocol Consultancy

Accurate choice/definition of endpoints during start up can maximise data potential

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.

Regulatory Compliance

Ensure clinical trial documentation provides a clear regulatory pathway for clinical development

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.