Two Prominent Computer Engineers Working with Programming Software on Personal Computer. In the Background Scientifically Advanced Research Center.

Biometrics Services

Led by industry experts, Pharmaron provides quality biometrics services ranging from Phase I to Phase IV in a wide variety of therapeutic areas. We are a Medidata-accredited vendor and our team is highly proficient with Rave EDC, Balance RTSM, CTMS and eTMF and CDISC standards including CDASH, SDTM and ADaM.

Data Management

  • Case Report Form (CRF, eCRF) design and review
  • Randomized trial and drug supply system design
  • Database design, build, test, maintain and close-out
  • Double data entry and comparison of paper-form data
  • Data verification and validation management
  • Data transfer
  • Medical coding
  • SAE and External data reconciliation
  • Local lab range management
  • Quality assurance and data management audit
  • EDC systems
Medical Bill Codes And Spreadsheet Data

Statistical Analysis and Programming

  • Power/sample size calculation
  • Protocol development and statistical methodology development
  • Adaptive design methodology implementation
  • Trial design input and simulation
  • Statistical Analysis Plan (SAP) and mock up shells development
  • Randomized schedule development and randomization list generation
  • Development of study data tabulation model (SDTM) datasets
  • Development of analysis datasets (ADaM) and derivation
  • Creation of tables, listings, and figures (TLF)
  • Support of publication and exploratory analysis
  • Interim analysis
  • Data Monitoring Committee (DMC) related statistical activities
  • Integrated summaries of safety and efficacy (ISS/ISE)
  • Annual or periodic safety reporting
  • Clinical study report review
  • Statistical analysis report