Preclinical WebsiteClinical Website

Eligibility & Safety Reads

We work with an international network of board-certified neuroradiologists and nuclear medicine physicians for central reads of MRI, PET, and SPECT images in clinical trials.

Centralized Neuroradiology & Nuclear Medicine Reads 

Centralized reads of MRI, PET, and SPECT images are a key element towards standardization in clinical trials. At Biospective, we specialize in operationalizing central neuroimaging reads for small (e.g. single center) to large (e.g. global, multicenter) clinical trials. 

Biospective works closely with the key stakeholders (e.g. Sponsor, Clinical CRO, sites) on various aspect of the central reading process, including:

  • Image acquisition protocols
  • Reader selection from our network of board-certified experts
  • Image Review Charter preparation (including read criteria)
  • Image transfer
  • Image quality control (QC) review and reconciliation
  • Well-defined turnaround time for read reports
  • KPIs for central review process

We use seamlessly integrated, regulatory-compliant software platforms to enable a smooth, end-to-end process. All data is meticulously tracked, and can be easily visualized for a high degree of transparency and real-time insights into our processes.

MRI Neuroradiology Reads

MRI is standard imaging modality for assessment of subject eligibility for study participation, as well as for monitoring the safety of therapeutic agents during the trial. Biospective is exclusively focused on neuroimaging in clinical trials, and our team of neuroradiologists, MRI physicists, and neuroscientists work closely with our Sponsor and their partners to define inclusion and exclusion criteria, safety measures, etc. as part of our central radiology reads services.

For specialized areas, such as Alzheimer's disease, our team has extensive expertise with centralized image reads Amyloid-Related Imaging Abnormalities (ARIA). ARIA-E and ARIA-H findings can be determined from FLAIR and T2*-weighted MRI scans, respectively. Similarly, our readers can identify White Matter Hyperintensities (WMH) and microhemorrhages as part of eligibility and safety assessments for a broad range of diseases.

MR Images of human brain for evaluation of Amyloid-Related Imaging Abnormalities (ARIA)

FLAIR MR images (top) for evaluation of ARIA-E and white matter hyperintensities; T2* GRE MR images (bottom) for assessment of ARIA-H and microhemorrhages. 

Amyloid & Tau PET Nuclear Medicine Reads

Amyloid and Tau PET imaging using a range of radiotracers have become standard modalities in Alzheimer's disease clinical trials. We work closely with a network of internationally-recognized nuclear medicine physicians with expertise in Brain PET reading based on standardized criteria. Amyloid PET eligibility and Tau PET eligibility reads can dramatically improve subject enrichment in clinical trials involving mild cognitive impairment (MCI) and Alzheimer's disease patients at various stages of disease progression. Our team works closely with imaging sites on implementation of image acquisition protocols that are optimized for central imaging reads of these Amyloid PET and Tau PET images. 

Different views of amyloid PET images for assessing subject eligibility for Alzheimer's disease clinical trials

Sagittal, coronal, and axial views of amyloid PET images for eligibility screening of subjects for Alzheimer's disease clinical trials.

Dopaminergic Imaging Nuclear Medicine Reads

Dopaminergic imaging using various PET and SPECT imaging radiotracers is now standard in Parkinson's disease clinical trials, but can be challenging to properly implement to acquire high-quality scans. At Biospective, our multi-disciplinary team of nuclear medicine clinicians, medical physicists, and image analysis scientists have established robust protocols for imaging of dopaminergic terminals. Properly reconstructed images are provided to our central readers to determine eligibility for study participation.

Different views of dopaminergic imaging scans for assessing subject eligibility for Parkinson's disease clinical trials

Sagittal, coronal, and axial views of dopaminergic imaging scans for eligibility screening of subjects for clinical trials of Parkinson's disease.

Learn more about our central Eligibility & Safety Reads services for clinical trials.

Explore our other Imaging Services


Can Biospective perform both visual reads and quantitative analysis of PET and SPECT images for study eligibility?

Definitely. We can perform parallel nuclear medicine (visual) reads and quantitative image analysis (e.g. Striatal Binding Ratio [SBR]) with rapid turnaround times to enable eligibility determinations, such as DaTscan eligibility criteria.

Can Biospective prepare an Image Review Charter?

Yes. We have extensive experience drafting comprehensive Independent Image Review Charters as part of our centralized image reader services. We account for the number of readers (e.g. single versus multiple readers), adjudication processes, reporting criteria, etc.

Can read reports be provided to the imaging sites?

Yes. Our Imaging Study Operations team will establish all of the workflows for the study, All imaging related information, including read report, is centrally managed via our unique Imaging Operations Management Platform (IOMP) software, and reports can be shared via tight access controls to key site personnel.

Can the Sponsor and its partners following the progress of the central reads?

Absolutely. Our Sponsors, their Clinical CRO, and the clinical & imaging sites can be provided with granular access to our secure, web-based analytics dashboards for tracking of the progress of the reads (from receipt to report finalization).

More Information

Let us know what you’re interested in. Our team will be happy to discuss with you!

Email us at i[email protected] or simply complete & submit the form below. 

Phone Number*
Affiliation (Company/University)*

Your privacy is important to us. We will protect your data as outlined in our Privacy Notice.

I agree to the terms in the Privacy Notice*

We use necessary cookies to make our site work. We also use other cookies to help us make improvements by measuring how you use the site or for marketing purposes. You have the choice to accept or reject them all. For more detailed information about the cookies we use, see our Privacy Notice.