REDEFINING THE STANDARDS
FOR DATA EXCELLENCE.

BIOSTATISTICS AND STATISTICAL PROGRAMMING

Our biostatisticians provide strategic statistical input to the clinical trial protocols with respect to the study design, including study objectives, endpoints, sample size, stratification and randomization, in order to ensure optimized clinical development plans. In addition, our biostatistics teams ensure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP), ICH guideline on Statistical Principles for Clinical Trial and CDISC standards.

The SAS programmers at eClinical Solutions have extensive industry experience, programming listings, tables, and figures across all phases of clinical studies and therapeutic areas. With robust internal processes to ensure industry best practices are implemented to support all levels of service, we’re able to address all the statistical data analysis and programming needs of our clients. Our team of experts ensures quality control is achieved for analysis datasets, tables, listings, and figures via automated checks and independent review according to dataset specifications or the SAP. We strictly enforce the following QC steps to ensure the highest level of quality in every phase of programming and data reporting:

  • Validation of programming specifications
  • Code review and validation
  • Data quality checks
  • Standard QC check lists are followed at various stages of clinical programming
  • All QC results, programmer actions, and resolutions are documented and archived

Our services include:

  • Study Design
  • Protocol Development/Review
  • eCRF design and review
  • Power and Sample Size Calculations
  • Randomization Schedule Preparation
  • Statistical Analysis Plan (SAP) Development
  • Statistical Consulting
  • Adaptive Design
  • Client Representation at Regulatory Agency Meetings
  • Development and quality control (via Independent Validation) of statistical Tables, Listings, and Figures
  • Interim Analysis Planning and Production
  • Topline Analysis Package Production
  • Final Analysis Package Production
  • DMC Statistical Services/li>
  • Protocol Development/Review
  • PK/PD Analysis
  • Integrated Summaries of Safety and Efficacy (ISS/ISE)
  • Statistical Reports
  • Statistical Review of Clinical Study Reports (CSR)
  • Development of CDISC compliant datasets (STDM, ADaM)
  • Submission-Ready Data Services (STDM, ADaM, OpenCDISC, Define.xml)

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603 West Street
Mansfield, MA 02048

India Office
1st Floor, CR1,
Prestige Shanthinikethan,
ITPL Road,
Bangalore – 560048