Early Phase Clinical Development

Delivering neuroimaging and digital biomarker solutions in early phase clinical development

Safety monitoring

We understand the importance of rigorous safety monitoring, with teams of expert neuroradiologists providing centralised real time reporting.

Radiological Reads

Scientific excellence

IXICO's clinical and imaging teams are experts in optimising the design and operational delivery of early phase clinical development.

Our collaborations

Staying flexible

We have a portfolio of image and biomarker analysis pipelines and also a range of tools to help develop and validate novel advanced algorithms.

LEAP algorithms

IXICO are unique in their extensive validation of therapeutic area-specific advanced imaging endpoints, which we would not find elsewhere.

Patient Stratification

There can be uncertainties in selecting the correct patient population

Typically an early phase trial protocol utilises inclusion criteria to ensure correct patient enrolment. There can be uncertainty in determining disease stage and/or differential diagnosis and imaging can be utilised to provide complementary markers (through visual radiological assessment and quantitative image analysis) for clinical trial enrichment in CNS therapeutic areas.

Patient-Centriticy

It is essential that the patient is at the centre of every clinical trial design

In early phase trial design, you want to obtain the best quality endpoint data, together with a flexible design to allow extraction of as much exploratory information as possible, but also to ensure the imaging sessions are within the limits of patient ability/tolerance. IXICO are experienced in supporting protocol development that optimises scanning protocols, sequences and endpoints.

Exploratory Endpoints

Maximise the ability to extract exploritory endpoints

It is often a requirement to explore a number of exploratory endpoints including new and novel data analytics. IXICO continuously adds to and advances the available analysis pipelines, looking at disease-specific regions of interest, indices, and other endpoints. It is important to ensure full validation and rigor around data collection, to enable use and translation into later-phase submission trials.

Engaging Consortia

Leverage the power of working with collaboration/consortia

Early phase development can benefit from engagement with the wider research community through collaborations and consortia.  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.