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Regulatory Leadership

Trusted Regulatory Expertise

Engage Bioclinica early in your drug development program to leverage an exceptional level of regulatory, scientific and operational expertise. For more than 30 years, Bioclinica has accelerated drug development research, working in tandem with regulatory bodies and key clinical research associations to establish core lab industry standards.

Bioclinica's unmatched scientific and regulatory leadership is well recognized and backed by ongoing professional relationships with key authorities and panels. We have an unprecedented number of successful, medical image data submissions on many high-profile drugs on the market today.

30
Years of Experience
70
Countries
130
FDA approvals

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Streamlined Regulatory Process

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. Bioclinica senior team members 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. Bioclinica ensures complete image data archival and all processes are in full compliance with 21 CFR Part 11.

Therapeutic Strength

Bioclinica offers extensive international experience including working in tandem with a wide array of organizations, across most major indications, in more than 70 countries. Working alongside global regulatory authorities, Bioclinica lead the advancement of Thorough QT (TQT) and Intensive QT trial design, highlighted by the completion of the first-ever TQT studies in China and Japan.

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Oncology Superiority

Bioclinica is proud to have contributed to 70+ FDA approvals for treating a wide variety of oncology indications. Our extensive medical experience, coupled with our commitment to quality, enables us to support every type of oncology trial.

Cardio-Oncology

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.

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ADDITIONAL RESOURCES

Seeking Clarity in the Audit Approach

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On Demand Webinar - Critical Regulatory Considerations for Imaging Trials: What You Need to Know

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Medical Imaging Services for Clinical Trials

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Oncology Imaging Expertise

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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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