The Biostatistics and Statistical programming team at GLC brings a deep understanding of the science of disease and compounds . Our experts blend scientific and technical knowledge to deliver more effective clinical designs, more detailed data analytics, and more accurate data interpretations to your clinical trial.
All our statisticians and statistical programmers receive ongoing, intensive training that incorporates:
Industry information such as 21 CFR Part 11
Good Clinical Practice (GCP) and ICH standards
SAS® software programming skills
Statistical methodology including adaptive design
With this proven approach, we collectively create successful teams, encourage knowledge sharing, and produce positive, productive interactions throughout the duration of our partnership.
Statistical Programming works closely with our Biostatisticians to carry out planned analyses, which include creation and QC of analysis datasets and tables, listings, and figures (TLFs). Our team ensures accurate results in a timely fashion. Quality control is achieved for analysis datasets, tables, listings, and figures via independent programming according to dataset specifications or the SAP, as appropriate, to ensure accurate results are provided to Biostatistics before final statistical review.
Statistical Programming Services
Working from planning to outputs and reporting, our statistical programmers are experts in CDISC standards and provide the right level of expertise through a flexible and agile resourcing solution to ensure quality project deliverables:
CDISC and ADaM Submission-ready Dataset Development and Quality Control for Submission Compliance
Analysis Dataset Development and Quality Control
Analysis Dataset Development and Quality Control for Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE))
Tables, Listings, and Figures Development and Quality Control
Tables, Listings, and Figures Development and Quality Control for ISS and ISE
Interim Analysis Support
Data Monitoring Committee (DMC), Safety Committee and Endpoint Committee Support
Provides many ad hoc analyses for publication summaries and external/internal review meetings.
Biostatistics
At our Biostatistics Department, our statisticians offer comprehensive support across all biostatistical facets. Our biostatistics services encompass:
Consultation on study protocol design
Sample size estimation
Development of randomization schedules
Developing statistical analysis plan
Conducting statistical analyses (both interim and final)
Publication of statistical analysis outcomes
Your Trusted Partner in Achieving Your Research Goals
At our core, we are committed to delivering exceptional service and driving the success of your clinical trials. Let us be your trusted partner in achieving your research goals.
Whether you are looking for a full-service clinical research partner or just need support in one specific area, our team at GLC is ready to help you achieve your goals. Contact us today and see how we can help you achieve your goals.
