A thorough understanding of imaging modalities, endpoints and scoring systems allows us to assign scientific experts to match the needs of your study, from protocol design through to regulatory submission.
Bioclinica provides extensive knowledge and experience to the design and implementation of clinical trials for inflammatory disease indications, including protocol and imaging charter development.
Large Network of Key Opinion Leaders
As an industry leader in imaging core lab services, Bioclinica has long-standing relationships with a large network of renowned academic and research Key Opinion Leaders (KOLs) who provide expert review, quality assessment, and imaging charter support.
Let our scientific expertise 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 is proud to have contributed to the FDA-approval of novel therapeutics for the treatment of inflammatory diseases.
Experience navigating the regulatory process
Bioclinica continues to accelerate drug development research, with an unprecedented number of successful, medical image data submissions for many high-profile drugs on the market today. Our experts have a deep understanding of imaging review charter and protocol development, adhering to guidance and directives from the FDA, EMA, and other international regulatory agencies. Our significant experience means effective trial conduct, preparedness for regulatory review and full compliance with 21 CFR Part 11.
Bioclinica maintains industry associations to maximize our clinical, technical and operational capabilities:
- American College of Rheumatology (ACR)
- American Medical Association (AMA)
- European Network for Cell Imaging and Tracking Expertise (ENCITE)
- International Society of Extremity MRI in Rheumatology (ISEMIR)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Drug Information Association (DIA)
- Radiologic Society of North America (RSNA)
- Uniform Protocols for Imaging Clinical Trials (UPICT)
- Qualitative Imaging Biomarker Alliance (QIBA)