Biostatistics

Croissance Clinical Research Inc have extensive experience providing biostatistical consulting and services from study design and protocol development to study analysis through regulatory requirements and agency meeting representation. Our statistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.

Engage our biostatisticians to support the planning and biostatistical analysis of your clinical trial and regulatory submissions projects. Or, partner with us to make our biostatistical team your team.

Explore Our Biostatistics Services:

Study design
Protocol development
Strategic statistical consulting
Sample size calculations
Endpoint development
Randomization schemes
Statistical analysis plans (SAP)
Adaptive Design clinical trial planning, simulation and implementation
Statistical tables, data listings, and figures for clinical study reports (CSRs)
eCRF design and review
Statistical analyses and reports
Pharmacokinetic and pharmacodynamic analyses
Regulatory Submissions - Regulatory guidance, planning, and meeting representation
Integrated safety and efficacy analyses (ISS/ISE/ISM)
Data Monitoring Committee (DMC) services
SDTM and ADaM dataset preparation (submission-ready dataset packages)

Statistical Programming

Statistical Programming provides a variety of services to understand the effect of a test product on safety, efficacy or other points of interest. Programming works closely with our Biostatistics team 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 the analysis of 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 the final statistical review.

In addition, Statistical Programming provides many ad hoc analyses for publication summaries and external/internal review meetings.

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.
Annual Clinical Trial Safety Updates
Data Monitoring Committee (DMC), Safety Committee and Endpoint Committee Support.