Imanet has insights into the challenges of PET in drug trials and experience providing solutions using PET imaging in clinical trials worldwide.
PK biomarkers
- Radiolabeled drug candidate studies
PD biomarkers
- Studies of drug candidate interaction with target system using a target-specific PET tracer
- Studies of drug effect on downstream systems using a PET tracer imaging physiology
Key components of Imanet’s PET services
- Expert advice on study design and data interpretation
- Access to an extensive bank of PET tracers
- Excellence in radiochemical labeling
- Rapid response to requests and reliable delivery to deadlines
- Compliance with local and national regulatory standards
- Project management of both single-center and multi-center studies
- Direct links with well-established CROs and clinical centers
- Full confidentiality
Our comprehensive imaging trial services include the following:
- Protocol development and integrated electronic CRF production
- Imaging site setup including safety evaluations, imagining procedures and hands-on training of personnel and alignment to local practices, ensuring the right combination of clinical expertise, patient population and imaging equipment
- Submissions to regulatory authorities and ethics boards including documentation ensuring regulatory compliance with the Imaging Manual, Image Quality Control Manual and Image Transfer Manual
- Image transfer, automated anonymization, comprehensive quality checks through effective real-time quality control and site feedback to reduce the number of non-evaluable image datasets
- Qualitative and quantitative analysis of results (safety, dosimetry and efficacy)
- Blinded reads, statistical analysis and endpoint reporting
To contact Imanet about the research services we provide, please e-mail imanet@ge.com.