Our Core Disciplines
Statistical Science
Biostatistics
Protocol and CRF review, statistical analysis plan (SAP) development, sample size and study design support, mock shell development for Tables, Listings, and Figures (TLFs), collaboration on SAP and TLF approval, support during database lock and treatment unblinding, and review of statistical sections of the Clinical Study Report (CSR).
Execution
Statistical Programming & Analysis
SAS programming and independent validation of Tables, Listings, and Figures (TLFs) for final and interim analyses, including outputs supporting Clinical Study Reports (CSRs). Review of TLF outputs by experienced biostatisticians, along with ad-hoc and post-hoc analyses to support study data review and additional analytical requirements.
Standardization
CDISC Clinical Data Standards
CDISC-compliant SDTM and ADaM dataset development and supporting documentation, including Define-XML, cSDRG, aCRF, and ADRG. Integrated summaries, including Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). SDTM and ADaM validation through independent double programming and Pinnacle 21 validation.
Documentation
Regulatory Medical Writing
Development of clinical study protocols and related documents for Phase 0–IV studies, including protocol amendments, synopses, outlines, and informed consent forms. Preparation of clinical study reports (CSRs) and supporting documents, including full, abbreviated, and synoptic CSRs, CSR appendices, addenda, errata, and synopses. Development of clinical subject narratives and preparation of responses to ethics committees and regulatory agencies.
Integrated Clinical Research Support
Supporting Every Phase of Clinical Development
Our integrated expertise supports key phases of clinical development, helping ensure consistency, quality, traceability, and regulatory readiness from study planning through final reporting.
SAP Support
Define-XML & Annotated CRFs
Independent QC & Validation
Development and review of Statistical Analysis Plans (SAPs) aligned with study objectives, statistical methodology, and regulatory requirements.
Precise Define-XML generation and annotated Case Report Forms (CRFs) supporting clear data definitions, traceability, and regulatory submission readiness.
Rigorous independent Quality Control (QC) and validation of statistical outputs and programming deliverables.
Let’s Discuss Your Clinical Research Needs
Connect with our experts to explore how StatsLibs can support your clinical development programs with precision and rigor.