approach

Clinical SAS programming

  • Statistical inputs for protocol design
  • Sample size calculation
  • Randomization/Blinding
  • SAS coding
  • Statistical analysis
  • Statistical report preparation
  • Support DSMB/DSRB conduct an interim analysis
  • Inputs into statistical analysis plan and mock tables
  • Write programming plan, specifications, rulebook using CDISC (SDTM/ADaM)/sponsor specific standards
  • Develop programs to perform required safety and efficacy analysis
  • Validation and parallel programming
  • Blinded data review
  • Develop macros when possible, especially for safety analysis, using SDLC
  • Develop programs to convert raw datasets to CDISC SDTM standards and mapping data across different standards
  • Support the regulatory submissions by creating SAS xpt files and define.xml

Biostatistics

Development of study design – Sample size/statistical power determination – Formulation of statistical analysis section of protocols – Describe both interim and final analysis strategies

Consult on statistical problems – Prepare for discussions with regulatory agencies – Hold planning sessions with customers to interpret or clarify analyses

Prepare integrated clinical/statistical reports – Design tables and graphics – Summary of all statistical methodologies and results

Support submissions to regulatory agencies – Present to regulatory agencies at advisory committee     meetings. Exploratory analyses for publications, abstracts, and marketing, including meta analysis

  • Protocol Preparation
  • Consultation/Planning
  • Report Preparation
  • Submission Support 
 
  • Full Support for Phase I-IV clinical trials Study design and consultation. Our experienced statisticians are committed to providing you with optimal clinical trial study designs to meet both regulatory and promotional needs.
  • Expert consultation for statistical issues relating to drug discovery, formulation, laboratory development, clinical development, evaluation/approval, manufacturing, and marketing research.
  • Regulatory Assistance in presenting statistical methods before regulatory authorities.
  • Protocol Development and verification of CRF design to ensure that data is collected in a manner to facilitate optimal statistical methods.
  • Randomization – Our statisticians consult and generate randomization schemes to meet your study requirements using an array of methods. Whether you require blinded envelope system, an interactive phone/web randomization system, or a simple unblinded open random schedule these are constructed in a highly controlled and secure environment.
  • Statistical Analysis Plan development – In concert with your focus and requirements, our expert statisticians provide a detailed analysis plan highlighting the methods and derivations in an a priori fashion.
  • Statistical Programming support for all phases of clinical trials. Our team of highly qualified and experienced statistical programmers provide all statistical output required according the statistical analysis plan and ad hoc requests.
  • Interim analysis and DSMB – Sristek provides full statistical and programming support for interim analyses and/or data safety monitoring boards in either a fully blinded or unblinded manner, depending on study requirements.
  • Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for NDA Submissions. Our statisticians and statistical programmers are well versed and experienced in providing critical statistical and programming support for NDA's and sNDA's.
  • Statistical Analysis Plans and Statistical Programming - We facilitate innovative statistical approaches that will increase your probability of a successful clinical trial.
  • Analysis Interpretation and Reporting -We help you to ensure that you make optimal decisions based on sample sizes, number of studies, analysis methods and precise interpretations of results.
  • Regulatory Services - We provide biostatistical support at regulatory meetings worldwide.
  • Data Integration - Access to a global pool of biostatisticians and resources enhances our ability to integrate data from multiple sources.
  • Advisory Panel and DMC Meetings - Our experienced team also provides statistical support and advice for advisory and data monitoring committee meetings.