Experience navigating through regulatory guidance
Bioclinica continues to accelerate drug development research, working in tandem with regulatory bodies and key clinical research associations to establish core lab industry standards. We have an unprecedented number of successful, medical image data submissions on 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 regulatory agencies. Our experts participate 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. Our staff ensures complete image data archival and our workflow complies with 21 CFR Part 11.
The association of many oncology drugs with cardiotoxic side effects necessitates independent cardiac safety studies for therapies in development. Bioclinica has extensive expertise in planning and implementing cardiac safety studies (ICH-E14 mandated Thorough QT services, blood pressure analysis, etc), facilitating the assessment of drugs early in clinical development.