illuminostics

our solutions

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illuminostics was created to accelerate the development of biomedical products through innovative trial designs, integrated informatics and expert project management.  As advances in radiology and diagnostic imaging occur daily, we meet the demands of our clients by providing real-time input and access to the latest experts with knowledge specific to the review technique, modality, or therapeutic area.

examples of illuminostics clinical trial imaging solutions:

  • Complete imaging core lab services
  • Image acquisition and transfer software and support (Core Grid®)
  • Imaging biomarker and scientific advise
  • Protocol/Charter development
  • Imaging-site selection and training
  • Centralized image reading and analysis
  • Imaging Quality Assurance
  • Comprehensive data management (including reconciliation and export)
  • Expert project management
  • Expert report and medical writing
 

how we work

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example clinical trial project

illuminostics has developed unique quantitative tools and graphical displays to augment conventional imaging technologies and more greatly aid the diagnosis and monitoring of human disease. An example of one such project is providing accurate measurement of liver iron concentration (LIC) through a non-invasive, spin density projection T2*-MRI imaging technology. This critical monitoring tool is used for managing patients with blood disorders such as thalassemia, sickle cell anemia, Diamond Blackfan anemia and myelodysplastic syndromes who are undergoing iron chelation therapy.

Our experience with the late-phase, multi-center international trials in utilizing LIC as a surrogate efficacy and safety endpoint required us to quantitatively normalize the multi-institutional data. The high enrollment international trials also present challenges due to differences in language, health care systems, regulatory environments, medical practice, and cultural background. We have come to learn through experience the importance of respecting the local specificities of each country, while placing extreme importance on assuring high standards and comparable data quality for each participating site.

Like other endpoints in clinical research, image parameters are associated with statistical variance, specific for each imaging methodology. Knowledge of these effects allows for appropriate statistical study design. The comprehensive project team at illuminostics uses our expertise to address all scientific, technical and clinical aspects of complex imaging studies.

smart & easy

The site-facing ImageInbox software runs in the web-browser environment supporting common Java™ enabled, thin-client download. This provides a lightweight and rapid deployment that’s HIPAA-secure and easy to maintain across a wide range of computer and Client IT policies (Firewall, port access, security compliance).

comprehensive

ImageInbox can directly capture DICOM images through network or file based transfers, as well as EEG data and a wide range of additional bitmap images.  

regulatory compliant

Core Grid and ImageInbox comply with all data privacy standards, such as HIPAA[1], regarding patient privacy regulations relevant to clinical and research applications. The software complies with FDA 21 CFR Part 11[2] and adheres to Good Clinical Practice (GCP) guidelines in clinical research involving human subjects.

[1] Health Insurance Portability and Accountability Act of 1996 (HIPAA; Pub.L. 104-191, 110 Stat. 1936, enacted August 21, 1996)

[2] Part 11, Electronic Records; Electronic Signatures — Scope and Application, http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm

automatic

With ImageInbox, image capture and transfer from the sending site can be configured for auto-pilot so that no active interaction is required, monitored using the dashboard-like control center

rigorous quality assessment/control

Each imaging trial includes quality assessment/control as its initial step. Standard assessments includes syntactic checks, e.g. completeness of study, correctness of labeling, etc., and semantic checks, e.g. image artifacts, signal-to-noise ratio, location match, etc., all of which are designed to ensure imaging protocol correctness and consistency. Illuminostics’ selection of checks is documented in the imaging charter and developed according to our internal SOPs

image processing/analytics

Image processing is a critical part of modern imaging research. Depending on the trial objectives and Client need, Core Grid provides a flexible system for plug-n-play integration with 3rd-party image processing systems (software or services). Also our in-house expert team of researchers and programmers can assist in developing necessary processing tools.

expert central and/or distributed review

The Core Grid software links in-house and remote reviewers together as a team to perform protocol specific review. The architecture supports common reviewer protocols, including RECIST and WHO.