The process of moving your drug or device from preclinical studies through FDA-regulated trials can be quite intricate, with many moving parts. Sponsors often have a hard time deciding whether to go with imaging analysis reads from the site’s radiology department, an independent radiologist, or a full-service imaging core lab. An imaging core lab has the manpower and experience to take sole responsibility for all aspects of a clinical trial’s imaging study design and independent image analysis. The benefits of a commercial imaging core lab are many, including regulatory compliance, access to imaging experts, operational reliability, experienced physician readers, and much more!
A commercial imaging group like Medical Metrics gives your company direct access to a vast ecosystem of experts. As a leader in clinical trial imaging, our internal staff has decades of experience and >50% of MMI staff hold advanced degrees in biomedical engineering, medical imaging and related fields. We have long-standing, active relationships with imaging scientists, KOLs, regulatory experts, biostatisticians, and industry veterans, all at your disposal when you partner with us. Our network of professionals assists your team with imaging study design, data interpretation, publication strategy, regulatory compliance, and more. When you partner with Medical Metrics, you have access to so much more than just independent analysis – you have a whole community here to help!
Clinical trial image analysis depends on structured, validated, literature-based grading systems and methodologies, which must be explicitly outlined at the beginning of a study. This analysis differs significantly from clinical interpretations of imaging for diagnostic purposes, which typically take the form of written prose in a report. Though any practicing physician may have the clinical know-how to treat a patient, they may not be well-versed with the specific norms of clinical trial reads. Differences in reading styles between physicians, not to mention lack of practiced consistency, can negatively impact your study outcomes. A commercial core lab helps you avoid such pitfalls. MMI’s reviewers are board-certified, practicing physicians with subspecialties matched to your study requirements. While our readers all have years of research and authorship in peer-reviewed journals under their belts, MMI takes things to the next level by providing tailored, active refresher training with every new project!
Navigating a regulated trial can be difficult, and it is imperative to do things by the book. Regulatory bodies expect your data to be securely recorded, stored, and reported with well-defined user access and audit trails linking outcomes to source images, electronic signatures, data retention, etc. At MMI, your study imaging is analyzed and stored in a FDA 21 CFR Part 11 compliant database that adheres to FDA and industry guidelines. This means that MMI’s database, purpose-built for clinical trials, is secure and validated with the appropriate audit trails. You can be confident that your data is safe and secure when running a regulated trial.
As a dedicated ISO-9001:2015-certified commercial imaging core lab, Medical Metrics is committed to delivering the highest quality of data. With an experienced internal team of QC staff, your data goes through additional scrutiny (e.g., trend tracking, outlier checks, etc.) to ensure there are no inconsistencies in your study imaging results. MMI guarantees the quality of the data, assures the independence of the imaging results, and assists sponsors in responding to regulatory inquiries about their imaging data. We also manage the entire process of reviewer recruitment, compensation, and management, as well as coordinate schedules to prioritize timelines of data deliverables. No need to worry about spending your own time and energy maintaining available and trained readers; working with MMI lets you focus on running your study!
Read more about how to choose the right reviewers and design your imaging study here!
Medical Metrics, Inc. is an ISO 9001:2015-certified provider of independent imaging core lab services and a leading core lab for clinical trials and related consulting. We assist sponsors with designing, implementing, and executing the imaging strategy of their global trials through our responsive trial management team, robust operating infrastructure, and world-class imaging expertise. Learn more about our Therapeutic Area expertise and our Services.
