Analytics Documents Development & Evaluation

We provide subject matter expertise and thought leadership on the development and evaluation of key analytics documents, including:

• Study Protocols

• Standalone Statistical Analysis Plans (SAP)

• Programming Requirements & Specifications (PRS) and Table, Listing, and Figure (TLF) Shells

• Analytic File Construction

• Real World Data (RWD) Quality Reviews

• Peer Editing of Study Reports, Abstracts, Posters, and Manuscripts

Model Development Plans

We work closely with our clients to review and provide expert guidance on the critical data and methods sections of Decision Analytic Model Development Plans (MDPs). Our input ensures the rigor of the proposed model structure, the plausibility and quality of all specified input parameters, and the appropriateness of the planned sensitivity analysis, thereby establishing a robust framework for subsequent health economic modeling.

Standalone Statistical Analysis Plans (SAP) 

We work collaboratively with clients to develop and review data and statistical sections of SAPs for Observational Research/RWE studies and development, review and guidance of programming requirements & specifications (PRS) documents to ensure programming quality and best programming practices. 

Analytic File Construction

We provide expert review and comprehensive guidance on the accuracy of Analytic File Construction. This critical process involves ensuring that all necessary variables are correctly created and aggregated at the appropriate level (e.g., event, person, or aggregate) to be fully suitable for meeting the stringent requirements of both regulatory-grade and high-standard academic analysis.