Clinical Research Organization

Biostatistics & Programming

R Square provides R and statistical programming, analysis and reporting services for clinical trial Phase I-IV, Health Economics and Outcomes Research.

 

Statistical Analysis Plan

SAP development includes individual studies as well as ISS/ISE.

  • Develop SAP

  • Prepare TFL Shells

  • Update SAP and Shells

  • Sign off SAP and Shells

SDTM

SDTM services includes CDISC compliant studies and legacy studies in submission format.

  • aCRF SDTM annotation

  • SDTM specifications

  • SDTM mapping

  • Independently validate SDTM domains

  • Pinnacle 21 validation

  • Create Define.xml

  • Create Study Data Reviewers Guide (SDRG)

  • Convert SDTM domains to transport file

  • SDTM transfer/Dry run and final SDTM transfers   

ADaM

ADaM production applies to individual studies as well as ISS/ISE.

  • ADAM specifications

  • Create ADaM datasets

  • Independently validate ADaM datasets

  • Pinnacle 21 validation

  • Create Define.xml

  • Create Analysis Data Reviewers Guide (ADRG)

  • Convert ADaM datasets to transport files

  • ADaM transfer/Dry run and final ADaM transfers   

 

Tables, Listings, Figures (TFLs)

TFL production applies to individual studies and ISS/ISE.

  • Create TFLs for CSR according to SAP and shells

  • Independently validate TFLs

  • Data quality review, data reconciliation and consistence checking

  • Dry runs and final transfer of TFLs

Data Monitoring Committee (DMC)

  • Create and Review DMC charter

  • Develop/Review SAP and TFL Shells

  • Set up firewall protected DMC study folder; Update database for DMC meeting; Create analysis datasets and TFLs: 2 sets of TFLs: Pooled and by scrambled Dummy Treatment. Perform independent validation.

  • Develop presentation slides for closed DMC session

  • TFLs delivery in sFTP encrypted method to IDMC committee members

  • Taking meeting minutes

Bioresearch Monitoring Program (BIMO)

BIMO preparation applies to all NDA and sNDA submission.

  • Clinical Study-Level Information Independently

         validate TFLs

    • A Comprehensive and Readily Located Table Listing All Clinical Sites That Participated in Clinical Studies

    • Table Listing All Entities to Whom the Sponsor Has Contracted Clinical Study-Related Activities

  • Subject-Level Data Line Listings by Clinical Site (Previously known as OSI listings (FDA Office of Scientific Investigations)

  • Summary-Level Clinical Site Dataset

    • Clinsite.xpt

    • Define.xml

    • BIMO Data Reviewer's Guide (bdrg.pdf): Recommended

    • BIMO Reviewer's Guide