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.