We've carefully assembled a team, each member an expert in their field with plenty of hands-on real-life experience, all so we can offer a full suite of services to help you with your clinical trial, all the way from the earliest stages of study design right on through to the preparation of the final archival data sets and reports to regulatory agencies.

We want to amaze you with our service, expertise, and transparency, and, most importantly, to provide you with peace of mind. We'll stake our reputations on it, and we won't let you down.


Study Design

  • Study design selection
  • Sample size determination
  • Develop randomization strategy
  • Case report forms (CRF) development
  • Protocol development
  • Create statistical analysis plans (SAP)
  • Define primary, secondary, and exploratory endpoints
  • Phenotype and exposure measure selection

Data Collection

  • Custom genotyping array development
  • Next-generation sequencing (NGS) strategy development
  • Database design and development, including first-pass data quality control
  • Web-based data management application design and development, including second-pass data quality control
  • Develop study data tabulation models (SDTMs)
  • Develop analysis data models (ADaMs)

Data Analysis

  • Genotype imputation
  • Next-generation sequencing (NGS) workflow
  • Data quality control
  • Data filtering
  • Data cleaning
  • Biomarker classification
  • Design and automate tables, figures, and listings (TFL) generation for ad hoc and final reports
  • Primary, secondary, and exploratory endpoint statistical analysis
  • Efficacy and safety analysis
  • Multivariate and prediction modeling and pathway analysis

Reporting

  • Design and automate the generation of datasets for export and reporting, including submission to dbGaP (the database of Genotypes and Phenotypes)
  • Liaison with federal regulatory agencies, including the United States' Food and Drug Administration (FDA)
  • Generate individual and aggregate biomarker reports
  • Develop material for clinical and annual reports

YOU CAN TRUST AND RELY ON US, EVERY STEP OF THE WAY