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Musculoskeletal

Advanced Musculoskeletal Medical Imaging

Shorten the decision-making process for musculoskeletal (MSK) clinical trials. With more than 30 years of experience, Bioclinica offers clinical trial sponsors and research institutions unmatched expertise, scientific insight, and proven centralized imaging services necessary to make timely, critical go/no-go decisions.

Bioclinica's MSK expertise includes support for the latest developments in imaging endpoints and a deep background in Rheumatoid Arthritis, Osteoporosis, Osteoarthritis, and more. Our medical affairs group, technologists, and dedicated MSK project teams have delivered quality service and independent image review in support of hundreds of MSK drug development and registration clinical trials.

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Leverage Customized Project Excellence

A thorough understanding of imaging endpoints allows us to assign the appropriate resources and scientific experts to match the needs of your study, from protocol design to regulatory submission. Furthermore, Bioclinica’s leading central independent image acquisition and analysis process improves image quality and standardization, providing for highly-reproducible, clean data.

  •   Protocol specific and standard procedural training

  •   Comprehensive site technologist training

  •   MSK dedicated project teams

  •   Multi-centered standardization of equipment

  •   21 CFR and GCP compliance with full audit trail

  •   Global operations for 24/7 support

  •   Custom and standard real-time online reporting

  •   Network of Key Opinion Leaders

Bioclinica's MSK Therapeutic Strengths

Rheumatic Diseases

  • Ankylosing Spondylitis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Gout

Pediatric Indications

  • Bone Growth Factor
  • Osteogenesis Imperfecta
  • Pediatric Bone Age

MSK Disease Integrity

  • Bone Mineral Density
  • Bone Repair
  • Fracture Studies
  • Osteoarthritis
  • Osteoporosis
  • Paget’s Disease

Bone Safety Assessments

  • Diabetes
  • COPD
  • HIV
  • Obesity

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support your next trial.

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Bioclinica's application of SMART in MSK

Bioclinica advances clinical trials via SMART — a robust suite of centralized medical imaging services designed to manage the complex imaging process from image receipt to analysis, to regulatory submission.

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

Expert Independent Review

Imaging endpoints play a central role in musculoskeletal trials, determining patient enrollment, prognosis, diagnosis, surveillance, safety, and clinical outcome. Our Musculoskeletal team has experience with the latest advancements in imaging modalities, scoring systems and outcome measures.

Bioclinica is highly conversant with all major quantitative assessment criteria systems and techniques, including:

  • Genant
  • Joint Space Width (JSW)
  • Joint space Narrowing (JSN)
  • Kellgren-Lawrence
  • OARSI
  • RAMRIS
  • Sharp/van def Heijde
  • Whole Organ MRI Score (WORMS)

Leaders in BMD evaluation

Clinical assessment of bone mineral density (BMD) is important for identifying bone loss and evaluating fracture risk in osteoporotic patient populations and is routinely used in clinical trials to monitor the safety of new therapies on skeletal health. Bioclinica has extensive experience with dual energy x-ray absorptiometry (DXA) measurements and is a leader in evaluating volumetric BMD and three-dimensional bone structure and geometry using sophisticated modalities including QCT

Leaders in Whole Organ MRI

Bioclinica's unrivalled scientific expertise is delivered through a strong Medical Affairs team, dedicated, sub-specialty trained radiologists and technologists as well as a large network of Key Opinion Leaders

Experienced Musculoskeletal Team

Bioclinica's unrivalled scientific expertise is delivered through a strong Medical Affairs team, dedicated, sub-specialty trained radiologists and technologists as well as a large network of Key Opinion Leaders

Leverage Bioclinica extensive knowledge and musculoskeletal experience to advance your trial:

  • Determination of trial specific endpoints
  • Development of imaging protocols and imaging charter
  • Design of independent review methodology
  • Delivery of high quality data

Bioclinica’s MSK Scientific Leadership

Key Opinion Leader Network

In addition to Bioclinica's network of internal and external sub-specialty trained physicians, Sponsors also benefit from our continued collaboration with renowned musculoskeletal key opinion leaders Drs. Ali Guermazi, Charles Peterfy, Harry Genant and Desiree van der Heijde.

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

Bioclinica’s transfer tools support a wide range of formats to meet client and project specifications — tools that enable clinical trial data delivery, including patient data and imaging data, to sponsors, external vendors, and partners.

LEARN MORE ABOUT THE SMART PROCESS

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ADDITIONAL RESOURCES

Medical Imaging Services for Clinical Trials

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Musculoskeletal Medical Imaging Expertise Sheet

Download OVERVIEW SHEET

Gastroenterology Endoscopic Expertise Sheet

Download OVERVIEW SHEET

Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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