Statistical Programming and Biostatistics
Biostatistical support.
Across the entire clinical development process.
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.
Biostatistical Services
- Provide statistical study design 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 for publications, abstracts, and marketing, including meta-analysis
Statistical Programming Service
- 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
Some examples of our experience
- Phase I-IV clinical trials in various therapeutic areas:
- Oncology
- CNS
- CV
- Inflammation
- Dermatology
- Rheumatology
- Ophthalmology
- Endocrinology/Metabolism
- Medical devices
- CDISC data standards:
- Quartesian is a CDISC Registered Solutions Provider
- Regulatory submissions support for more than 100 accepted studies
- Innovator products
- Biomarker
- Exploratory studies
- Pivotal Phase III studies
- CNS Studies:
- Continuous and categorical data
- SAPS
- CGIC
- PGIC
- MADRS
- HAM-D
- CSS
- Oncology studies:
- Expertise in application of RECIST and irRECIST criteria guidelines in Tumor Response Evaluation
- Analysis and summary of the study endpoints, response rates, OS, PFS, DFS, functional status, and more
- Generic drugs
- BA/BE
- Clinical endpoint studies
