Modality Expertise

Radiography (X-rays)

Bioclinica is well-versed with the oldest and most well-known, imaging modality used in the regulatory approval process around the globe for clinical indications, such as rheumatoid arthritis. Our team understands that the proper acquisition technique for the assessment of cartilage, Joint Space Width (JSW), and Joint Space Narrowing (JSN) in osteoarthritis studies is critical and needs to be standardized to ensure the subtle changes are precisely measured.

Magnetic Resonance Imaging (MRI)

Bioclinica has successfully completed numerous studies utilizing MRI and the MRI scoring systems recommended by OMERACT for both RA and PsA. Bioclinica collaborates with world experts for the Whole Organ MRI Score (WORMS) method to assist with image or 3-D reconstructions for cartilage volume and bone marrow edema. MRI images in Ankylosing Spondylitis (AS) can be read with methods developed by Spondyloarthritis Research Consortium of Canada (SPARCC).

Dual Energy X-Ray Absorptiometry (DXA)

From methodologies for cross-calibration and instrument quality control (IQC) to careful assessment of patient acquisition and analysis using GE Lunar or Hologic software, Bioclinica ensures all patient data is analyzed accurately and precisely.

• Phantoms Boclinica has developed and utilize imaging phantoms for qualification of DXA instruments used in musculoskeletal clinical trials.

• The BonaFide DXA Phantom (BFP) enables instrument verification over a clinically relevant range of bone mineral densities (BMDs).

• The Bioclinica Body Composition Phantom (BBCP) enables monitoring of machine drift and simulates different soft tissue and bone compositions.

Quantitative Computed Tomography (QCT)

Quantitative Computed Tomography is used to measure accurate three-dimensional BMD.

Achieve Clarity through Innovative Imaging Methods

• Syn-X-RA™ frame: X-ray positioning device

• Syn-M-RA™ frame: Hand MRI positioning device

• Genant modification of the Sharp scoring method

• OMERACT RAMRIS MRI scoring method

• Quantitative analysis of MRI pulse sequences

Images are electronically uploaded from trial sites, blinded and rigorously quality checked. Bioclinica employs a "Multi-Step Quality Control" process that ensures the image data received from the sites will be of the highest quality.

We track all patients enrolled in studies and all imaging data generated during the course of a clinical trial. Our expert technicians use innovative tools to deeply review, update, and assure compliance with clinical trial protocols and defined reading paradigms. This enables queries to be issued, tracked, and resolved. Our ICL collection management process is designed to detect early on any substandard image quality or violations of the imaging protocol.

Our imaging core lab collection management process includes:

• Collect image data
• Query sites for missing data
• Translate/digitize image data
• Image QA/QC
• Image data query resolution
• Archive for long-term storage
• And more

With Bioclinica, you’ll receive powerful, comprehensive reporting services for sites and sponsors, which supports the management and review of data for clinical trials.

Gain access to real-time reports, such as:

• Metrics reports

• Project status reports

• Custom client reports

• Analysis results reports

• Safety and eligibility reports

• Billing reports