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:

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

SAS Statistical Programming Services:

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