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.

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.

We conduct targeted or systematic literature reviews to inform comparative effectiveness and confounder selection, incidence and prevalence across indications, treatment patterns, and outcomes.

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.

Design and conduct of cost effectiveness studies and data to support HTA/payor needs.

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.