Please Wait...

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
200
FDA approvals

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support your next trial.

CONTACT US

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.

Learn More

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.

ACHIEVE GREATER SUCCESS WITH IMAGING IN NAFLD/NASH STUDIES

ADDITIONAL RESOURCES

Seeking Clarity in the Audit Approach

Read Blog

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

Watch On Demand Webinar

Medical Imaging Services for Clinical Trials

Download Brochure

Oncology Imaging Expertise

Download OVERVIEW SHEET

Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

We think you should have access to the full suite of #ClinicalDataManagement services to ensure high-quality, relia… https://t.co/jVuliQwFo3
Bioclinica (5 days ago)
A mid-study change to a new #IRT vendor can be required for a number of reasons and can introduce a certain amount… https://t.co/sU7akWjdCD
Bioclinica (1 week ago)
A clinical trial rescue or transition presents a unique set of challenges for study teams. Join us on July 21 for a… https://t.co/rlYiFYpR6G
Bioclinica (2 weeks ago)
Rapid #CTMS implementation shouldn’t mean sacrificing features and functionality. With a modular approach, a full-f… https://t.co/gwqFtB8lhe
Bioclinica (3 weeks ago)
How prepared are you for a #clinicaltrial transition? With proper planning, the impact to sites and patients can be… https://t.co/vOqwC5vzzd
Bioclinica (4 weeks ago)
Think a #CTMS implementation takes too much time and too many resources? It doesn’t have to. Learn how a configurab… https://t.co/kH7sOltbbU
Bioclinica (4 weeks ago)