Our goal is to enhance your clinical research by leveraging a wide spectrum of validated, contemporaneous, real-world data sources that support your prospectively defined analysis plans, regulatory submissions and product development goals.
We also understand the importance of applying ethical and quality standards to real-world data acquisition and analysis. Our dedicated team of data managers, data scientists, and biostatisticians identify, mitigate, and account for bias that could negatively impact inference from your studies involving Real-World Data (RWD) and Real-World Evidence (RWE) for pharma and medical devices.
We look forward to talking with you, learning more about your specific goals and determining how we can help you.
Patient and subject-reported outcomes as well as experiential data are now required endpoints for certain regulatory approvals in vaccines, epilepsy, migraine or Crohn’s disease. While biomarkers, subgroups, and other response predictor models derived from trial or real-world data offer more informed guidance on subsequent trial designs, mitigating future study risks.
Beyond its impact on improving patient care and clinical trial designs, RWD and RWE for pharma and medical devices also influence manufacturers’ product development and lifecycle management decisions. For example, many in vitro diagnostic tests require proof of clinical and real-world utility in order to be considered reimbursable by insurers including Medicare.
From rare disease study recruitment to control-arm data acquisition and post-marketing commitments, our RWE and RWD team can also partner you in expanding access to comprehensive sources to enhance your Phase I-IV studies, registries and other clinical research ambitions.
Experience Sheet
Innovative Solution to Gathering Real-World Data from Patients and Clinicians
