Design and conduct for RWE submissions in 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.

Identification of suitable data sources for novel research questions, data assessments of EHR/EMR and genomic data by indication to determine fitness of data. Extensive experience with medical claims databases (US, Ex-US), electronic health record data (US, ex-US), genomic, and registry data.

Design and conduct of natural history, burden of disease, treatment patterns, comparative effectiveness, and safety. We provide end-to-end study execution including study design, protocol and statistical analysis plan writing, analysis, study report and slide decks, and manuscript writing.

Provide data management support including but not limited to generation of feasibility assessment forms, questionnaires, data cleaning, and data quality and missingness checks.

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

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.

Programming services include end-to-end programming with SAS or SQL including primary coding and quality control (QC) including code review and independent QC (also referred to as double programming). We also provide regulatory-grade execution and firewalling of data.