Observational data are often required to meet complex mandates by regulators and payers to demonstrate real-world product value, safety and effectiveness. In the absence of suitable sources of secondary data (e.g., literature, healthcare databases, electronic medical records), it is necessary to engage in primary data collection to generate this evidence.
Our real-world data collection team designs and executes studies that result in tailored, fit-for-purpose data to demonstrate real-world value of biopharma products and medical devices. In many cases, these data may be used to populate and validate economic models, or aid in the development and implementation of PRO instruments. We leverage our payer network and the insight it generates to design effective prospective studies.
Evaluate outcomes of interest with direct to participant surveys, typically conducted via electronic data collection with no need for study sites.
Build upon the available data with a cross-sectional or longitudinal database analysis of Rx and/or medical claims plus patient and/or site reported data.
Understand efficiency/time savings with a prospective time and motion study.
Evaluate burden-of-illness, patterns and/or costs of care, or patterns of drug utilization and (in)appropriate use via data abstraction from medical charts.
Gather real-world clinical, health economic, outcomes research, or safety related endpoints to supplement or complement data from other studies.
Ensure that the benefits of your product outweigh the risks utilizing our dedicated risk management team of regulatory, safety, and epidemiology experts. Read the fact sheet.