Regulatory-Grade Solutions
We design and generate RWE for regulatory submissions including externally controlled trials (ECTs), natural history, benchmarking studies, and epidemiological support on orphan drug applications, pediatric study plans, diversity plans, and (s)BLAs/(s)NDAs.
Observational Studies
We design and conduct a range of observational studies including burden of disease, comparative effectiveness & safety, and external control arms. We provide end-to-end execution including study design, protocol and analysis plan writing, analysis, study report, and publications.
Literature Reviews
We conduct targeted or systematic literature reviews to inform comparative effectiveness and confounder selection, incidence and prevalence across indications, treatment patterns, and outcomes.
Data Landscaping
We identify suitable data sources for novel research questions and conduct data assessments by indication to determine fitness of data. We have extensive experience with medical claims databases, electronic health record data, genomic, and registry data.
Health Outcomes Research
Design and conduct of cost effectiveness studies and data to support HTA/payor needs.
Medical Writing
Our writing services include protocol and statistical analysis plan writing, and abstract, poster and manuscript development. Experience with medical writing in the context of real-world evidence.
We offer flexible and custom solutions to meet your needs. Contact us to initiate a dialogue.