Imaging Protocol Development
Strong endpoints start with a strong imaging protocol. We design imaging protocols, acquisition guides, and image review charters that align with your clinical protocol and anticipate regulatory scrutiny. Every assessment and criterion is grounded in the published literature and current FDA guidance, so your imaging endpoints are defensible from the first patient to the final report.
Site Qualification and Training
Consistent images start at the site. We qualify each site, train imaging staff, and review early submissions to confirm quality before problems affect your data. Training is documented and verified, and we retrain promptly when we see deviations, so you get fewer non-evaluable images and a stronger dataset.
Image Collection, Storage, and Management
Every image is inspected, de-identified, tracked, and reconciled against enrollment records, with queries managed from issue to resolution. Our systems are 21 CFR Part 11 compliant, with electronic signatures, audit trails, and secure, redundant storage, so your imaging data is complete, protected, and audit-ready.
Expert Image Analysis: Quantitative and Qualitative
Our trained analysts apply validated methods to deliver precise, reproducible quantitative measurements. Independent, board-certified subspecialty radiologists, cardiologists, and other specialists provide blinded qualitative review against clearly defined grading criteria, with a structured adjudication process to resolve disagreements objectively.
Project Management and Quality Control
Senior scientists stay involved from start to finish. A dedicated project manager keeps your trial on schedule with clear timelines and on-demand status reporting. Reader training, ongoing quality monitoring, and performance testing keep results consistent from the first visit to database lock
Scientific Data Analysis and Interpretation
We deliver clean, quality-controlled datasets and help you make sense of them. LSR supports interim and final analyses, exploratory and subgroup analyses, interpretive reports, and publication, turning imaging results into clear, credible conclusions for regulators and the clinical community.
