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Biostatistics

For nearly 20 years customers from all segments of the healthcare research sector (pharmaceutical, biotechnology, vaccine and medical device) have trusted CROMSOURCE to handle their data.

CROMSOURCE has worked across many therapeutic areas and in all phases of clinical development. From intense and complex early phase trials, to huge registry studies and complex medical device investigations, CROMSOURCE delivers high quality and cost efficient solutions.

Often our clients rely require CROMSOURCE to expertly manage all biometric aspects of their projects from protocol development and sample size calculation to final study report. Our experience allows us to identify the most efficient and cost-effective approach to completing your research.

The CROMSOURCE philosophy is always to leverage our experience and expertise to support each and every client regardless of their size or project scope. This philosophy ensures each and every assignment receives the same dedication, ownership and team. In short, CROMSOURCE delivers.

Consulting

  • regulatory interaction – FDA/ICH/EMA and advice (including CDISC integration)
  • SOP writing services
  • training courses
  • process improvement
  • statistical support on-site

Design

  • sample size calculations
  • randomization
  • protocol development and clinical study planning
  • statistical analysis plan (SAP)
  • presentations of study design to regulatory agencies

Analysis

  • final and/or interim
  • (blind) data review meeting
  • inferential analysis
  • pharmacokinetic services
  • generation of summary tables, figures and listings with SAS
  • CDISC (SDTM / ADaM / define.xml)
  • updating historic study data to CDISC standards.
  • development of Data Monitoring Committee charters and timely interim data reports.

Reporting

  • statistical report – ICHE3 compliant and CSR ready
  • comprehensive support for Clinical Study Report Writing
  • contribution to publications arising from the study results
  • integrated summaries (ISS, ISE) and regulatory dossiers (NDA/PMA submissions)

 

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