Core Lab Operations
We have structured our core lab operations around a rolling read paradigm as opposed to the batch read system prevalent in our industry. An imaging provider conducting batch reads will collect data, hold it and then analyze it all at once prior to a milestone delivery date. Conducting rolling reads allows us to analyze images as we receive them giving us tighter quality control while making us more nimble and fluid; we are always prepared to deliver study data whether it is a special needs request, interim database upload or final database lock.
Likewise, conducting rolling reads gives our sponsors greater flexibility during studies. Since we provide routine data deliveries throughout the life of the study, as opposed to only at milestone dates, sponsors have earlier access to data that may enable them to make critical changes mid-study. Providing sponsors with greater confidence in their active decision making during early phases can be a key to helping reduce late stage attrition.
While we recommend trials use a rolling read paradigm for the benefits listed above, there are situations where customers require Collect and Hold which we are happy to accommodate. Our organizational structure and flexibility enable us to operate efficiently using either a collect and hold or rolling read program ensuring the specific needs of our clients and their studies are met.
Our core lab was designed with an integrated, regulatory compliant (21 CFR Part 11) analysis system that ensures a complete electronic audit trail. Our core lab is staffed by an in-house team of imaging technologists and radiologists that adhere to a strict Statistical Quality Control Process maximizing the precision and reproducibility of the data acquired, analyzed, and delivered to our customers.