Bioclinica is proud to have contributed to the development of FDA-approved drugs designed to treat metabolic and endocrine disorders. Our extensive medical experience, combined with our technology and quality services, enables us to support clinical trials with efficacy and safety endpoints.
Examples of FDA approved drugs supported by Bioclinica
|Humatrope||Growth Hormone Deficiency|
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 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.
The established off-target effects of diabetes medications have resulted in increased regulatory examination into bone safety and formal FDA guidance surrounding cardiovascular safety for new antidiabetic therapies (Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, December 2008). Bioclinica has extensive expertise in planning and implementing cardiac safety studies (Thorough QT services, blood pressure analysis, cardiac imaging, etc.), facilitating the assessment of CV risks early in clinical development.
Bioclinica ensures complete image data archival and all processes are in full compliance with 21 CFR Part 11.