Bioclinica is proud to have contributed to FDA and EMA drug and device approvals for musculoskeletal indications. Our extensive medical experience, combined with our technology and quality services, enables us to support your musculoskeletal trial.
Examples of approved drugs or devices supported by Bioclinica
|Zeledronic Acid||Male Osteoporosis|
|Epoch FullCoat Hip||Hip Replacement|
|Kiva VCF Treatment System||Vertebral Compression Fractures|
Experience navigating the regulatory process
Bioclinica continues to accelerate drug development research, working in tandem with regulatory bodies and key clinical research associations to establish imaging core lab industry standards. We have 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. Bioclinica participates in FDA meetings and workshops, taking an active leadership role in shaping new guidance surrounding imaging endpoints in clinical trials. Our significant experience in charter and protocol development means effective trial conduct and preparedness for regulatory review. Bioclinica ensures complete image data archival and all processes are in full compliance with 21 CFR Part 11.