Biostatistics & Statistical Programming

Sainalytics offers biostatistical services in Clinical Trials phases I to IV and Real World Evidence and Outcome Research. These services are provided to the pharmaceutical industry as a part of a clinical study, as a stand-alone or as a consulting service.

We have proudly delivered expert clinical trial statistical analyses and programming to all phases of drug development in a wide range of therapeutic areas. In that time, our biostatisticians and SAS® programmers have built a reputation of excellence by being responsive and collaborative, producing quality deliverables, and maintaining the highest level of scientific integrity

When you work with us, you can be as hands-off or as hands-on as you want to be.  For example, you can provide just the study protocol, SAP, data and CRFs, and we'll deliver validated output.  Or, you can provide us very detailed specifications and perform the validation in-house. Whatever your biostatistical or clinical trial programming needs, Sainalytics staff have the skills and experience to produce high-quality, accurate, on-time deliverables. 

Biostatistics is a necessity for clinical trials, and making sure you choose the right statistical advisor is imperative. Our extensive operational experience in this field provides a competitive advantage for your drug development program.

Protocols and statistical analysis plans are the most important documents in your drug development program. The Sainalytics statistical team has experiential knowledge about statistical methodology and their applications to clinical trials and drug development. Our biostatisticians use the most valid and powerful statistical analysis methods to maximize the probability of technical success of your program.

Our services include:

  • Protocol development, including sample size and power calculations
  • Randomization schedules
  • SAP Development and Review
  • Randomization Schedules
  • Writing statistical sections of the clinical study report (CSR) & Review
  • Statistical Tables, Figures, and Listings development
  • CDISC Implementation (SDTM and ADaM Datasets, SDTM Annotated CRF, define.xml Files)
  • Support for IDMC and Support of data and safety monitoring boards (DSMB)
  • Development Safety Update Report (DSUR) support
  • Integrated summaries of safety and efficacy
  • Pharmacokinetic (PK) and Pharmacodynamics (PD) analysis
  • CRF Tabulations and Patient Profiles
  • Data Management Listings
  • Edit Checks
  • General SAS Dataset Remapping/Restructuring
  • Creating define.xml and data reviewer’s guide documents for both SDTM and ADaM
  • Performing consistency checks, which are beyond Pinnacle 21 validation checks, for define.xml against aCRFs and databases