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Biostatistics Services

Biostat & SAS Statistical Programming

Exciting innovations in data analysis and visualizations are paving the way for a better clinical experience. Our global clinical biostatistics and programming team offers a deep understanding of the science of disease areas and compounds and provides efficient upfront study design and comprehensive planning assistance.

Biostatistical Services:

  • Bullet Pharmaceutical product development planning, Sample Size estimations, study design, and analysis, as well as supporting methodologies and statistical analysis plans
  • Bullet Clinical protocol development, Case report form, and Clinical study report review
  • Bullet Planning and implementing Study final and interim analysis
  • Bullet Publication support and Ad-hoc analysis
  • Bullet Support for all phases of clinical trials, from initial dose titration through post-approval services

SAS Statistical Programming Services:

  • Bullet Validated Macros bring efficiency, cost savings, and accelerated timelines.
  • Bullet CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)
  • Bullet Experience with most major EDC platforms
  • Bullet Derived dataset production and validation
  • Bullet TLF production and validation
  • Bullet Regulatory submissions (Development of integrated ADaM datasets for ISS/ISE analyses, Define.XML)
  • Bullet Submission-ready datasets and programs

MakroCare statisticians, who are all at the Ph.D. or M.S. level, are familiar with regulatory requirements and skilled in robust statistical methodologies. Our statistical programmers are versatile and experienced in the use of SAS, enabling us to generate QA report summaries and listings to meet your specifications.

We understand the highly confidential and sensitive nature of clinical data. MakroCare follows the stringent information security guidelines of ISO 27001, covering access authorization and control, confidentiality protection, and several other protective measures.

The First Step

Let's talk about how MakroCare can help you