STATISTICAL PROGRAMMING AND BIOSTATISTICS
Let us handle the data so you can focus on running your program.
Biostatistics is at the core of every clinical study from design and protocol development, to analysis and reporting. Get the right support for your trial — throughout the entire clinical development process — and ensure that the correct data is captured and prepared for analysis.
Our highly skilled team of biostatisticians provide biostatistical consulting and services for pre-clinical, clinical, registration phase, and post-marketing studies, including regulatory submission and agency meeting representation for accurate, accessible and reproducible high quality clinical data. We ensure biometrics operations are compliant and up to date across a variety of different regulations, including: 21CFR, ICH GCP, US-FDA, UK/NICE
SI, EU CTR, and more.
KPS Life proudly partners with Quartesian to offer best-in-class Data Management and Biostatistical programming services. Our synergistic and seamless offerings enhance the quality of your clinical operations resources and allows you to better understand your data, resulting in true strategic control of your trial.
- Provide statistical study design and expertise for defining the study
- Protocol development and review: Including statistical sections, sample size, power calculations, and randomization methodology
- Randomization plan development, schedule generation, review and implementation, IVRS, and IWRS support
- Blinded/Unblinded data review and analysis support
- Statistical Analysis Plan development and mock shells creation with adaptable approaches
- PK and PK/PD analyses and modeling
- Analysis of cardiac safety data (pilot and thorough QTc studies)
- Support and provide consultancy for Data and Safety
- Monitoring Board (DSMB), DMC, and interim analysis
- TLFs review and interpretation of results
- Exploratory analyses of publications, abstracts, and marketing, including meta-analysis
Statistical Programming Services
- Data mapping and submission to regulatory agencies
- Table, listing, and figure (TFL) creation and validation
- Support Biostatistician in PK/PD parameter calculations
- ISS(SCS)/ISE(SCE) analysis
- Observational study analyses
- Legacy study data mapping and conversion
- CDISC services – SDTM – ADaM – Define.XML – Reviewer’s Guide
- Post-marketing data analyses and reporting
- eCTD submission support
- Patient profile reports, PD listings, BIMO listings, and Narratives
- Regulatory query support