"Assimilating clinical data into integrated and measurable outcomes"

From planning, collecting raw data to securing it till data analysis is concluded, efficiently without compromising deadlines, quality and budget.The whole process is carried out under regulatory-compliant and disciplined methodologies. Our well experienced team of programmers and biostatisticians are here to provide expert guidance and consultation for statistical methodology, programming and generating reports using the licensed statistical software to support interpretable outcomes.

Database Management Activities

  • Provide inputs for the Protocol development
  • Case Report Form (CRF) development: EDC/Paper
  • Electronic Database Development (EDC)
  • Prepare the Data Management Documents
  • Data Cleaning using the Data Review tools and reports, and query management
  • Code using the MedDRA and WHO-DD dictionaries
  • Provide quality data for statistical analysis
  • Database lock

Bio-statistics Services

  • Effective sample size calculations
  • Statistical inputs to the protocol
  • Review the study Case Report Form (CRF) based on the study objectives in consideration
  • Study Statistical Analysis Plan (SAP)
  • Randomization Support and inputs for IWRS/IVRS set-up
  • Data Analysis as per study objectives

Statistical Programming Services

  • Generate accurate Tables, Listings and Figures
  • Generate the Study Analysis Reports
  • Prepare the CDISC package for global regulatory submission. This package includes:
  • CDISC Conversion (Mapping of legacy and on-going studies datasets to SDTM)
  • Generation of Analysis sets (ADAM)
  • Creation of CDISC documentation (Reviewer’s guide; Define.xml)
  • Provide planned and ad-hoc request to prepare the DSMB/DMC review
  • Support ad-hoc data report requests from the global regulators as a part of the post-submission process

Speciality Statistical Services

Customised solutions of the programme through statistical PK/PD Modelling, providing inputs on the Statistical Reports (as part of CSR, Manuscripts, IB) and Study Objective Analysis.

  • Lead/support planning and preparing the integrated safety and efficacy summaries for global regulatory bodies, including FDA, EMEA etc.
  • Global Regulatory Consulting and Representation
  • Carrying out either of the blinded or un-blinded for Interim analyses or Futility analysis (go/no-go decision)
  • Lead and/or contribute as an expert DSMB/DMC statistician
  • Act as an as Independent Statistical Centre
  • Perform Interim Analyses
  • Provide inputs to support research/scientific publications and responses to the editorial comments

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