At Geistek, we combine data science, technology, and statistical expertise to ensure every dataset is accurate, traceable, and compliant.
Our Data Management and Biostatistics teams work as an integrated unit, turning complex trial data into actionable insights that withstand regulatory scrutiny and accelerate approval.
Comprehensive data lifecycle management for clinical and preclinical programs:
Design, build, and validation of electronic data capture (EDC) systems.
Query management, discrepancy checks, and audit-ready processes.
Full traceability with rigorous documentation and version control.
Statistical Analysis Plans (SAP), descriptive & inferential statistics.
Modeling of pharmacokinetic/pharmacodynamic relationships and biomarkers.
Predictive modeling, risk-based monitoring, and algorithmic optimization of patient enrollment and endpoints.
All processes aligned with CDISC, GCP, and FDA/EMA data standards.
We make sure your data tells a clear, defensible story, from first entry to final submission.
Data integrity is not just a deliverable, it’s a culture.
We don’t just manage data, we engineer evidence.
Our data and biostatistics experts collaborate with clinical, regulatory, and medical writing teams for complete alignment.
eClinical tools (EDC, ePRO, eTMF) and automated validation pipelines for real-time visibility.
Every database follows standardized build protocols, traceability matrices, and multi-level validation.
Every dataset is versioned, traceable, and accompanied by automated audit trails.
Bayesian, adaptive, and model-based methods available to optimize study power and design.
QA involvement throughout the study lifecycle to ensure inspection readiness.
Multi-disciplinary team of biostatisticians, data scientists, and regulatory data specialists.
Fully integrated workflows between Data Management, Biostatistics, and Medical Writing.
Experience with oncology, gene therapy, and medical device datasets.
Compliance with global standards: CDISC SDTM/ADaM, ICH-E9, ISO14155.
Agile resourcing model for short- or long-term projects.
100% inspection-ready documentation and audit trail preservation.
