How CP-MIC can Help

Do you need to incorporate medical imaging into your programmes - but not sure how?

This could be:

• Translating your preclinical pharmacology into an imaging strategy for clinical implementation

• Needing help with your imaging strategy to ensure it can deliver within the time-frame of your clinical path

• Embedding imaging into a clinical protocol

• Developing a novel imaging agent or methodology

• Understanding the GMP validation process of imaging agents to enable human use

• Understanding regulatory requirements when using imaging methods in your clinical protocols

• Knowing when and how to implement safety imaging into your clinical protocols

• Incorporating multiple imaging methods into one protocol and not sure how or if feasible

• Needing to validate a non-imaging biomarker via the use of an imaging biomarker

• Needing to run a study across multiple sites (within or between countries) and are unsure how to set-up and/or operationalise

• Requiring help selecting an imaging CRO for your study

• Unsure if an imaging strategy is needed for your programme but would like to enquire

There is never a “one size fits all” solution for applying medical imaging into programmes, with each imaging strategy/study requiring a considered approach to ensure it delivers on the required endpoints for clear decision-making. Having your imaging strategy/study clearly defined and correct at the outset can save considerable resource in terms of time and finance.

At CP-MIC we can help deliver the following:

Imaging Strategy Setting

✅ Clarifying your imaging needs

✅ Creating and optimising an imaging strategy to suit the specific endpoint requirements for your programme

✅ Aligning your imaging strategy to designated resources (i.e. timelines and finance)

Clinical Requirements

✅ Develop a path for generating and delivering imaging specific data and documentation for regulatory submissions (e.g. GMP tracer validation, micro-toxicity)

✅ Build safety imaging endpoints into protocols (where required)

✅ Facilitate the use of clinical imaging agents in countries where they are authorised and un-authorised

✅ Support the authoring of imaging-related sections into clinical documentation

Operationalisation of Medical Imaging

✅ Design a path for implementation of multiple tracers and/or multiple imaging modalities at clinical imaging sites

✅ Guide the development of a novel imaging agent or method

✅ Optimise the conduct of clinical imaging across multiple sites (within or between countries)

✅ Assist in the selection of an imaging CRO