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SMS-oncology

Data management

Reliable clinical data is important to show “proof of concept” (PoC) in early phase trials and to build a regulatory-compliant dossier for later submission to authorities. Our Data management team can assist you in delivering high-quality validated data on time, on budget, and in compliance with industry and regulatory standards.

SMS-oncology’s data management in short:

  • Team experience on average ~15 years
  • Experts in development of oncology specific eCRFs and databases
  • Accustomed to short turnaround timelines
  • Quality and reliability of data is our #1 priority
  • Compliant with industry standards (CDISC, CDASH and SDTM data collection)
  • End-to-end data management services
  • Can work as stand-alone function

Full range of data management services:

  • (electronic) Case Report Form (CRF) design
  • EDC set-up & clinical database design
  • Comprehensive User’s Acceptance Testing (UAT)
  • Fit-for-purpose EDC Training
  • Data validation
  • Data reconciliations
  • Query management
  • Medical coding
  • Data Imports
  • Data Transfers
  • SDTM datasets and SDTM submission package

The overview of our data management process and capabilities is shown in the figure below:

Electronic data capture (EDC) system:

SMS-oncology is highly experienced in working with various Electronic Data Capture (EDC) platforms. This enables us to tailor-make high-quality databases for your projects.

IBM® Clinical Development

SMS-oncology uses IBM® Clinical Development from Watson Health™ (previously known as eClinicalOS system from Merge Healthcare). This 21 CFR Part 11 compliant, cloud-based EDC system delivers a single clinical trial operating platform available anywhere, any time. While EDC is the core, this all-encompassing solution offers several powerful options, from randomization, drug dispensing and reporting to Source Data Verification (SDV), Medical Coding, Lab Normals, electronic Patient Reported Outcomes (ePRO) and endpoint adjudication. These clinical trial capabilities can be mixed and matched to build a solid foundation for each trial environment. Advantages of IBM® Clinical Development:

  • Single URL for access to all studies
  • Available 24/7/365
  • Configurable eCRFs, study visit schedules and cleaning workflow
  • Multiple subject revision moves
  • Real time reporting
  • On-demand data exports (i.e. SAS, CSV, XML)
  • On-demand study documentation (i.e. subject PDFs, database design document)
  • Automated data archival

Biostatistics:

Our full range of Biostatistics services includes:

  • Statistical Analysis Plan (SAP)
  • Statistical programming and analysis
  • Dose Escalations
  • Interim Analysis
  • Study design and sample size calculations
  • Randomization
  • Data listings and summaries
  • PK/PD analysis
  • Statistical input and review of clinical study reports
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