Invicro‘s clinical team members are experts in multi-modality clinical imaging and analysis (PET, SPECT, MRI, CT) and can perform single- or multi-site clinical imaging research across all stages of the drug development pipeline (phase I-IV). Our researchers have a long history of developing and optimizing radiolabeled pharmaceuticals and biologics (peptides, antibodies, etc) and are highly experienced in study site set-up, management, and image quality assurance techniques that produce high-quality and highly consistent imaging data.
Our clinical imaging center coordination and project management program includes:
- Radioligand production site qualification and oversight
- Radiochemistry regulatory oversight including IND submission
- Imaging center evaluation, selection, set-up, training and management
- Core imaging lab services to receive and quality control imaging data and provide rapid analysis for study eligibility
- Quantitative analysis for monitoring drug effect
- Image data management
- Regulatory compliance services
To learn more about these core lab services, click here.
In addition to multi-center trial management, our on-site clinic equipped with SPECT and PET instrumentation is an ideal setting for single-site trials. The clinical imaging team has undergone multiple agency audits and hundreds of sponsor audits and has fully validated 21CFR Part 11 compliant systems. Our clinical facility is complete with a medicinal chemistry lab for tracer development and a cGMP Radiochemistry lab for radioligand production and distribution. Studies run at our on-site clinic are also supported by our skilled program managers and advanced analytics teams.
The demonstration of drug penetration of its target organ, drug engagement of its molecular target and modification of its target activity are known as the Three Pillars of Drug Development – and are required for a large scale investment required to move a novel drug to large scale clinical testing.
Molecular and functional imaging are unparalleled in their ability to deliver information on the Three Pillars in the translational phase between late pre-clinical and early clinical phases. Imaging studies are non-invasive, can be done in small, well defined populations and produce objective and reproducible outcome measures that allow Go-No-Go decisions to be made.
Invicro is the world’s leading translational imaging company, combining cutting edge methodological expertise with decades of pharma and biotech experience and expert biological and clinical knowledge. This combination makes Invicro unique in being able to provide the optimal imaging biomarker support across all phases of drug development. Invicro has unrivalled expertise in the design, conduct, analysis and interpretation of imaging studies to deliver information that will allow critical decision making.
Positron Emission Tomography (PET) – A molecular imaging technique that uses bespoke ligands labelled with short lived isotopes to quantify molecular targets in the living organism. PET combines sub-picomolar sensitivity and unique molecular specificity to allow the investigation of multiple molecular targets. PET imaging in early clinical development, often in parallel with the first in human studies, helps determine the drug distribution, target interaction and downstream pharmacology of novel drugs. Such information can be used to provide dosing information for proof-of-concept studies, which has been demonstrated to reduce both cost and time in early stage development.
Invicro possess the world’s largest PET radiochemistry group, with facilities in the UK and the US for the discovery and characterisation of novel radioligands, labelled with 11C, 18F as well as longer lived isotopes, in a variety of pre-clinical species. Invicro radiochemistry has speciInvicro in-house human imaging facilities in London and New Haven, are supported by GMP radiochemistry and Pharma grade analysis, operations and regulatory groups. These facilities have been designed to conduct focused, early phase PET studies for Pharma and biotech.
Magnetic Resonance Imaging (MRI) – A flexible non-invasive medical imaging modality, used to investigate the anatomy and physiology in both health and disease. MRI scanners use magnetic fields and radio waves to form images of the body. Invicro provides a range of MRI solutions including:
- Functional MRI (fMRI) – to understand how different parts of the brain respond to external stimuli
- Structural MRI – to provide detailed images of soft tissues in the body to monitor disease progression in areas such as inflammatory arthritis, respiratory disease and neurodegeneration
- Magnetic Resonance Spectroscopy (MRS) – for measuring metabolism and target metabolites in a variety of tissues.
Invicro MRI group has extensive expertise in the application of various MR based methods to drug development. Human MRI facilities based in London allow the performance of in-house studies for clients in a high level GMP/GCP environment.
The availability of both PET and MRI at Invicro internal facility allows the design, conduct and efficient delivery of multi-modal studies combining PET with MRI to deliver a comprehensive characterisation of novel pharmaceuticals.
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